Bendiocarb (assessment report as finalised on 22.09.11).

Assessment Report: UK BENDIOCARB September 2011

Assessment Report of 91

Directive 98/8/EC concerning the placing of biocidal products on the market

Inclusion of active substance in Annex I to Directive 98/8/EC

Assessment Report

Bendiocarb

Product-type 18 (Insecticides, acaricides and products to

control other arthropods)

22 September 2011

Annex I - UK



Bendiocarb (PT 18)

Assessment report

Finalised in the Standing Committee on Biocidal Products at its meeting on 22 September 2011 in view of its inclusion in Annex I to Directive 98/8/EC

CONTENTS

1 STATEMENT OF SUBJECT MATTER AND PURPOSE 4

1.1 Procedure followed 4

1.2 Purpose of the Assessment Report 5

1.3 Overall conclusion in the context of Directive 98/8/EC 5

2 OVERALL SUMMARY AND CONCLUSIONS 7

2.1 Presentation of the active substance 7

2.1.1 Identity, physico-chemical properties and methods of analysis 7

2.1.2 Intended uses and efficacy 7

2.1.3 Classification and labelling 7

2.2 Summary of the risk assessment 9

2.2.1 Human health and companion animal risk assessment 9

2.2.2 Environmental risk assessment 23

2.2.3 List of endpoints 34

3 DECISION 34

3.1 Background to the decision 34

3.2 Decision regarding inclusion in Annex I 36

3.3 Elements to be taken into account by Member States when authorising products 37

3.4 Requirement for further information 38

3.5 Updating this Assessment Report 38



APPENDIX I: LIST OF ENDPOINTS 39

Chapter 1 Identity, physical and chemical properties, classification and labelling 39

Chapter 2 Methods of analysis 42

Chapter 3 Impact on human health 43

Chapter 4 Fate and behaviour in the environment 49

Chapter 5 Effects on non-target species 52

Chapter 6 Other end points 54

APPENDIX II: LIST OF INTENDED USES 55

APPENDIX III: LIST OF STUDIES 58



1. STATEMENT OF SUBJECT MATTER AND PURPOSE

1.1. Procedure followed

This Assessment Report has been established as a result of the evaluation of Bendiocarb as product-type 18 (Insecticides, acaricides and products to control other arthropods), carried out in the context of the work programme for the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC concerning the placing of biocidal products on the market1, with a view to the possible inclusion of this substance into Annex I or IA to the Directive.

Bendiocarb (CAS No. 22781-23-3) was notified as an existing active substance, by Bayer S.A.S. Bayer Environmental Science (former name Bayer Environmental Science), hereafter referred to as the Applicant, in product-type 18.

Regulation (EC) No 1451/2007 of 4 December 2007,2 which has repealed and replaced Commission Regulation (EC) No 2032/2003 of 4 November 2003,3 lays down the detailed rules for the evaluation of dossiers and for the decision-making process in order to include or not an existing active substance into Annex I or IA to the Directive.

In accordance with the provisions of Article 5(2) of Regulation (EC) No 2032/2003, the UK was designated as Rapporteur Member State to carry out the assessment on the basis of the Dossier submitted by the applicant. The deadline for submission of a complete Dossier for Bendiocarb as an active substance in Product Type 18 was 01/05/2006, in accordance with Annex V of Regulation (EC) No 2032/2003.

On 28/04/2006, the UK competent authority received a Dossier from the applicant. The Rapporteur Member State accepted the Dossier as complete for the purpose of the evaluation on 28/07/2006.

On 01/04/2008, the Rapporteur Member State submitted, in accordance with the provisions of Article 10(5) and (7) of Regulation (EC) No 2032/2003, to the Commission and the applicant a copy of the evaluation report, hereafter referred to as the Competent Authority Report. The Commission made the report available to all Member States by electronic means on 08/04/2008. The Competent Authority Report included a recommendation for the inclusion of Bendiocarb in Annex I to the Directive for PT 18.

1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing biocidal products on the market. OJ L 123, 24.4.98, p.1

2 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. OJ L 325, 11.12.2007, p. 3

3 Commission Regulation (EC) No 2032/2003 of 4 November 2003 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market and amending Regulation (EC) No 1896/2000. OJ L 307, 24.11.2003, p. 1



In accordance with Article 16 of Regulation (EC) No 1451/2007, the Commission made the Competent Authority Report publicly available by electronic means on 09/04/2008. This report did not include such information that was to be treated as confidential in accordance with Article 19 of Directive 98/8/EC.

In order to review the Competent Authority Report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the Commission. Revisions agreed upon were presented at Technical and Competent Authority Meetings and the Competent Authority Report was amended accordingly.

On the basis of the final Competent Authority Report, the Commission proposed the inclusion of Bendiocarb in Annex I to Directive 98/8/EC and consulted the Standing Committee on Biocidal Product on 22 September 2011.

In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the present assessment report contains the conclusions of the Standing Committee on Biocidal Products, as finalised during its meeting held on 22 September 2011.

1.2 Purpose of the Assessment Report

This Assessment Report has been developed and finalised in support of the decision to include Bendiocarb in Annex I to Directive 98/8/EC for product-type 18. The aim of the Assessment Report is to facilitate the Authorisation in Member States of individual biocidal products in product-type 18 that contain Bendiocarb. In their evaluation, Member States shall apply the provisions of Directive 98/8/EC, in particular the provisions of Article 5 as well as the common principles laid down in Annex VI.

For the implementation of the common principles of Annex VI, the content and conclusions of this Assessment Report, which is available at the Commission website4, shall be taken into account.

However, where conclusions of this Assessment Report are based on data protected under the provisions of Directive 98/8/EC, such conclusions may not be used to the benefit of another applicant, unless access to these data has been granted.

1.3 Overall conclusion in the context of Directive 98/8/EC

The overall conclusion from the evaluation is that it may be expected that there are products containing Bendiocarb for the product-type 18, which will fulfil the requirements laid down in Article 10(1) and (2) of Directive 98/8/EC. This conclusion is however subject to:

i. compliance with the particular requirements in the following sections of this Assessment Report,

4 http://ec.europa.eu/comm/environment/biocides/index.htm



ii. the implementation of the provisions of Article 5(1) of Directive 98/8/EC, and

iii. the common principles laid down in Annex VI to Directive 98/8/EC.

Furthermore, these conclusions were reached within the framework of the uses that were proposed and supported by the applicant (see Appendix II). Extension of the use pattern beyond those described will require an evaluation at product authorisation level in order to establish whether the proposed extensions of use will satisfy the requirements of Article 5(1) and of the common principles laid down in Annex VI to Directive 98/8/EC.



2. OVERALL SUMMARY AND CONCLUSIONS

2.1. Presentation of the Active Substance

2.1.1. Identity, Physico-Chemical Properties and Methods of Analysis

The main identification characteristics and the physico-chemical properties of bendiocarb are given in Appendix I to this document. The active substance must be technically equivalent to the specification given.

The methods of analysis for the active substance as manufactured and for the determination of impurities have been validated. The methods of analysis in environmental matrices, as appropriate for the areas of use assessed, have been validated and shown to be sufficiently sensitive with respect to the levels of concern.

2.1.2. Intended Uses and Efficacy

The assessment of the biocidal activity of bendiocarb demonstrates that it has a sufficient level of efficacy against the target organisms and the evaluation of the data provided in support of the efficacy of the accompanying product, establishes that the product may be expected to be efficacious.

In addition, in order to facilitate the work of Member States in granting or reviewing authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and the common principles laid down in Annex VI of that Directive, the intended uses of bendiocarb, as identified during the evaluation process, are listed in Appendix II.

2.1.3. Classification and Labelling

Active Substance (Bendiocarb)

The classification of bendiocarb is currently assigned according to Annex I of Council Directive 67/548/EEC and is presented in Table 1.1.

Table 1.1 Current classification of bendiocarb based on 67/548/EEC

Classification T: Toxic Xn: Harmful N: Dangerous for the environment

R-phrases

R23: Toxic by inhalation. R25: Toxic if swallowed. R21: Harmful in contact with skin. R50/53: Very toxic to aquatic organisms. May cause long-term adverse effects in the aquatic environment.1

1 There are no special concentration limits specified for the Dangerous Substances Directive 67/548/EEC environmental classification.

On the basis of a review of the data submitted, it is considered that the current classification (as detailed in Table 1.1) is appropriate.



The proposed classification and labelling of bendiocarb based on CLP Regulation is shown in Table 1.2.

Table 1.2 Proposed classification of bendiocarb based on CLP Regulation SIGNAL WORD DANGER Classification Acute Tox. 2 – Oral

Acute Tox. 2 – Inhalation Acute Tox. 3 – Dermal Aquatic acute 1 (M factor of 10 applicable) Aquatic chronic 1 (M factor of 100 applicable) [Environmental warning symbol, warning label]

H-Statements H300: Fatal if swallowed H330: Fatal if inhaled H311: Toxic in contact with skin H400: Very toxic to aquatic life H410: Very toxic to aquatic life with long lasting effects

Biocidal Product (Ficam W) Ficam W contains 80 % w/w pure bendiocarb. The current classification of ‘Ficam W’ is presented in Table 1.3.

Table 1.3 Current classification of ‘Ficam W’ guide recipe based on 67/548/EEC

Classification T: Toxic Xn: Harmful N: Dangerous for the environment

R-phrases

R23: Toxic by inhalation. R25: Toxic if swallowed. R21: Harmful in contact with skin. R50/53: Very toxic to aquatic organisms. May cause long-term adverse effects in the aquatic environment.

Based on the review of product data submitted for Ficam W, the UK CA disagrees with the current classification, as detailed in Table 1.3. Studies with Ficam W demonstrated acute toxicity by the oral and inhalation routes that met the EU criteria for classification as Toxic (T; R25, R23), whereas the available information did not support classification for acute toxicity by the dermal route. As such, the UK CA’s proposed classification of Ficam W is presented within Table 1.4.



Table 1.4 Proposed classification of ‘Ficam W’ guide recipe based on 67/548/EEC

Classification T: Toxic N: Dangerous for the environment

R-phrases

R23: Toxic by inhalation. R25: Toxic if swallowed. R50/53: Very toxic to aquatic organisms. May cause long-term adverse effects in the aquatic environment.

The proposed classification and labelling of ‘Ficam W’ guide recipe based on CLP Regulation is shown in Table 1.5.

Table 1.5 Proposed classification of ‘Ficam W’ guide recipe based on CLP Regulation SIGNAL WORD DANGER Classification Acute Tox. 2 – Oral

Acute Tox. 2 – Inhalation Aquatic acute 1 (M factor of 10 applicable) Aquatic chronic 1 (M factor of 100 applicable) [Environmental warning symbol, warning label]

H-Statements H300: Fatal if swallowed H330: Fatal if inhaled H400: Very toxic to aquatic life H410: Very toxic to aquatic life with long lasting effects

In addition, the product can be diluted with water and applied at an in-use concentration of 0.3 % w/w technical bendiocarb. The diluted product (0.3% w/w technical bendiocarb) is classified for the environment: H410: Very toxic to aquatic life with long lasting effects.

2.2. Summary of the Risk Assessment

2.2.1. Human Health and Companion Animal Risk Assessment

2.2.1.1. Hazard identification

2.2.1.1.1. Toxicology hazard summary

The potential for bendiocarb and Ficam W (containing 82.47 % w/w technical bendiocarb) to cause adverse health effects has been investigated in studies in laboratory animals. For repeated oral, inhalation and dermal administration, genotoxicity, carcinogenicity, reproductive toxicity and neurotoxicity, information on bendiocarb has been used to predict the likely health hazards of Ficam W.

Several studies in a number of laboratory animal species have indicated that bendiocarb is acutely toxic by the oral route and meets the EU criteria for classification as Toxic (T; R25). Two acute dermal studies in rats indicate that for this endpoint, bendiocarb meets the EU criteria for classification as Harmful (Xn; R21). One acute inhalation study with bendiocarb in



rats indicates that a classification as Toxic by inhalation is appropriate (T; R23). Studies with Ficam W demonstrated acute toxicity by the oral and inhalation routes that met the EU criteria for classification as Toxic (T; R25, R23), whereas the available information did not support classification for acute toxicity by the dermal route.

Bendiocarb was only mildly irritating to the skin and eyes; Ficam W did not demonstrate any skin or eye irritancy. Although no specific information was available on the ability of bendiocarb or Ficam W to irritate the respiratory tract, there was no information from other studies to indicate that they had this property. Neither bendiocarb nor Ficam W met the EU classification criteria for skin, eye or respiratory tract irritation and, hence, no further consideration will be given to the irritation end-point in the risk characterisation.

Bendiocarb and Ficam W were negative in guinea pig tests for skin sensitisation; these findings were supported by the absence of sensitisation responses in repeat-dose dermal studies and in medical surveillance data on manufacturing plant personnel, and by the general lack of sensitising activity in carbamate insecticides (Baron, 1991). There is no specific information to determine the potential of bendiocarb or Ficam W to induce respiratory sensitisation; however, there are no structural alerts for bendiocarb, there have been no reports of respiratory sensitisation in medical surveillance data on manufacturing personnel, and the co-formulants of Ficam W are not classified for respiratory sensitisation. Therefore, no classification for skin or respiratory sensitisation is proposed, and these end-points will not be considered further in the risk characterisation.

The most sensitive markers for identifying NOAELs for use in the risk characterisation were considered to be inhibitions in brain and erythrocyte cholinesterase activities: inhibitions of 20 % or greater were considered to be toxicologically significant. Therefore, only repeated-dose studies that provided such measurements were used to derive NOAELs for use in the risk characterisation. The repeated-dose toxicity of bendiocarb has been investigated by the oral route in rats (dietary studies of 90 days and 104 weeks duration) and dogs (dietary studies of 112 days and 104 weeks duration). There were no treatment-related mortalities or overt clinical signs of toxicity in any of the studies. In both the sub-chronic and chronic studies, the dog was more sensitive than the rat; therefore, these studies were chosen to take forward in the risk characterisation. Although a two-year exposure does not constitute a life-time study in dogs, this study provided a lower NOAEL than that which used the rat. Following oral exposure a NOAEL of 1 mg kg bw-1 d-1 was identified from the 112 day dog study for use in short-term oral exposure scenarios; and a NOAEL of 0.65 mg kg bw-1 d-1 from the two-year dog dietary study for use in long-term oral exposure scenarios.

The repeated-dose toxicity of bendiocarb has been investigated by the dermal route in rats (a 21-day study) and rabbits (a 21-day study). In the rat study, bendiocarb was applied as Ficam W. No mortalities occurred at any dose level. Toxic effects, which were consistent with exposure to this class of chemical, were observed from 200 mg kg bw-1 d-1 in a dose-response relationship and were severe in the highest-dose group (800 mg kg bw-1 d-1). The effects appeared 30-45 minutes after each dosing but were rapidly reversible, having resolved within 24 hours of treatment initiation. As erythrocyte and brain cholinesterase activities were not measured, this study will not be considered further in the risk characterisation. In the rabbit



study, bendiocarb was applied as Ficam Plus (31 % active substance). No mortalities occurred, and the only overt sign of toxicity was a slight, transient erythema in some animals. At necropsy, diffuse, minimal epidermal thickening was seen in the treated skin of all male and three female rabbits in the high-dose group. A NOAEL of 1.67 mg kg bw-1 d-1 was determined, based on inhibitions in erythrocyte cholinesterase activity.

The repeated-dose toxicity of bendiocarb has been investigated by the inhalation route in rats (studies of 14 days and 13 weeks duration). No treatment-related deaths occurred in either study. In the 14-day study, clinical signs (rigid tails, unsteady gait, slight tremors) were observed immediately after exposure in the 50 and 100 mg m-3 groups but had resolved by one hour after dosing. Statistically significant reductions in body-weight gain occurred in male rats in the 50 and 100 mg m-3 groups (54 and 71 % decrease over days 0-14), and the terminal body weights were lower than the controls (11 % and 13 %, respectively). The body weights and body-weight gains of females were less affected than those of males. As erythrocyte and brain cholinesterase activities were not accurately measured, this study will not be considered further in the risk characterisation. In the 13-week study, no treatment-related clinical signs were observed, and body-weight gain and food consumption were unaffected by treatment. Exposure to bendiocarb had no effect on ophthalmoscopic examination, haematology, organ weights, macroscopic abnormalities or clinical chemistry other than acetylcholinesterase activity. Brain cholinesterase activity was reduced at 13 weeks in the 20 mg m-3 group (by 26 % in males and 22 % in females). A treatment-related effect was noted on the incidence of aggregations of alveolar macrophages in the lungs of males in the high-dose group. The NOAEC was determined to be 2.0 mg m-3 based on the inhibitions in brain cholinesterase activity, which converts to a systemic dose equivalent of 0.6 mg kg bw-1 d-1.

Bendiocarb did not meet the EU criteria for classification for repeated-dose toxicity by the oral, dermal or inhalation routes. Similarly, as none of its co-formulants are classified for repeated-dose toxicity, no classification for Ficam W is appropriate.

Bendiocarb was negative in five in vitro Ames and gene mutation assays. A positive result was obtained in an in vitro cytogenetics assay in cultured human lymphocytes; however, it was negative in an in vivo bone marrow cytogenetics assay and two additional in vivo assays (a mouse micronucleus test and a rodent dominant lethal test). The data do not support classification for mutagenicity. Likewise, as none of the co-formulants are classified for mutagenicity, no classification for Ficam W is appropriate.

The carcinogenic potential of bendiocarb has been investigated in life-time dietary studies in rats and mice. No carcinogenicity or neoplastic changes were observed in either species at concentrations that significantly reduced survival in mice and resulted in brain cholinesterase inhibition in rats. Although the survival rate in the rat study was low at two years, this study combined with the mouse study and the absence of genotoxicity indicate that bendiocarb is not carcinogenic. The available data do not support classification for carcinogenicity. Additionally, as none of the co-formulants are classified for carcinogenicity, no classification for Ficam W is appropriate.

The developmental toxicity of bendiocarb has been investigated in standard rat and rabbit oral (gavage) studies. There was no indication that bendiocarb is a developmental toxicant. The



available data do not support classification for developmental effects. Additionally, as none of the co-formulants are classified for developmental toxicity, no classification for Ficam W is appropriate.

The effects of bendiocarb on fertility have been investigated in a three-generation oral (dietary) reproduction study in rats. There were no indications that bendiocarb affected fertility. The available data do not support classification for fertility effects. Additionally, as none of the co-formulants are classified for fertility effects, no classification for Ficam W is appropriate.

The potential for bendiocarb to cause delayed neurotoxicity has been investigated in an oral (gavage) neurotoxicity study in hens. No signs of neurotoxicity were reported in hens following a single dose that resulted in mortalities. Additionally, as none of the co-formulants are known to cause neurotoxicity, Ficam W would not be expected to have this effect.

2.2.1.1.2. Critical endpoints

For risk characterisation for repeated exposure, one critical effect, inhibition of brain and/or erythrocyte cholinesterase activity, was identified from studies in dogs, rats and rabbits. This effect may arise from short-term and long-term oral, dermal or inhalation exposure scenarios.

The inhibitions in cholinesterase activity observed after bendiocarb administration are directly attributable to its insecticidal mode of action, which is to reversibly inhibit acetylcholinesterase. The inhibitions in cholinesterase activity and the clinical signs associated with them are rapidly reversible on cessation of exposure, with no long-term effects.

There are slight species differences in susceptibility to the toxic effects of bendiocarb, although all species tested responded to exposure with clinical signs that were typical of a reversible carbamate cholinesterase inhibitor (including muscular fibrillation, urinary incontinence, salivation, tremors, lacrimation and reduced activity). In acute oral studies, the cat was the most sensitive of the tested species. In repeated-dose studies, dogs were more sensitive to the inhibition of cholinesterase than were rats. In the absence of any information on human susceptibility to the anti-cholinesterase effects of bendiocarb, the toxicity observed in dogs, rabbits and rats repeatedly exposed to bendiocarb by the oral, dermal and inhalation routes, respectively, will be considered to be potentially relevant to human health.

In a 112-day oral dog study, a NOAEL of 1.0 mg kg bw-1 d-1 was identified based on toxicologically significant inhibitions in brain cholinesterase activity. This value is proposed for use in the risk characterisation of anti-cholinesterase activity in acute/medium-term oral and dermal exposure scenarios.

In a 13-week rat inhalation study, a NOAEC of 2 mg m-3 was identified, based on toxicologically significant reductions in brain cholinesterase activity. This value is proposed for use in the risk characterisation of anti-cholinesterase activity in acute/medium-term inhalation exposure scenarios.



For long term exposure scenarios, a two-year dietary study in dogs is used. A NOAEL of 0.65 mg kg bw-1 d-1 was identified, based on toxicologically significant inhibitions in brain cholinesterase activity.

Data are also available in cats exposed to bendiocarb, with an acute oral LD50 value of 11 mg kg bw-1 reported; no adverse effects being reported at 0.5 mg kg bw-1 (the lowest dose tested). In addition, no adverse effects were reported in cats exposed for 15 days in a room to a dust containing bendiocarb at a coverage rate of 20 g m-2 (equivalent to 0.2 g m-2 bendiocarb).

2.2.1.1.3. Uncertainties

Dermal Absorption Values Used in the Risk Assessment

A dermal absorption study has been conducted with Ficam W on dermatomed human skin. Ficam W, formulated in water, was applied for eight hours, and the receptor fluid was sampled for 24 hours. Recovery of radiolabel in the study was 91 % (range: 86 – 9). At the end of the study, 3.3 % (range: 1.8 – 6 %) of the applied dose had reached the receptor fluid, 1.1 % (range: 0.2 – 2.9 %) was found in the skin below the stratum corneum, while 0.5 % (range: 0.2 – 1.0 %) was retained within the stratum corneum. The entire stratum corneum was removed using only 5 tape strips, the mean residue levels being 0.223, 0.117, 0.100, 0.077 and 0.043 % of the administered dose in strips 1, 2, 3, 4 and 5, respectively. If residues in the first 2 strips of the stratum corneum are not considered to be systemically available, then a dermal absorption value of 4.631 % is obtained. Overall, the UK proposes to round up this figure and use a dermal absorption value of 5%. Although another study is available on the dry powder, it is noted that the powder was not moistened when applied to the skin and so, it is not considered appropriate to use the dermal absorption value from the study in the risk characterisation.

Overall, a dermal absorption value of 5 % will be used in the risk characterisation for all dermal absorption.

Inter- and Intra-species Variability

Oral exposure to bendiocarb results in acute, fatal toxicity to a number of laboratory animal species and, on repeated exposure, inhibitions in brain and erythrocyte cholinesterase activity in dogs and rats. Dermal exposure to bendiocarb results in acute, fatal toxicity to rats and, on short-term repeated exposure, inhibitions in erythrocyte cholinesterase and alkaline phosphatase activity in rabbits. Inhalation exposure to bendiocarb results in acute, fatal toxicity to rats and, on short-term repeated exposure, inhibitions in brain cholinesterase activity and an increased incidence of aggregation of alveolar macrophages in rats. There is no definitive information available to identify the relative sensitivities of humans compared with experimental animals in relation to the ability of bendiocarb to cause these effects. Similarly, there are no data to reliably inform on the potential for inter-individual variability in susceptibility to the effects. Given these uncertainties, standard default factors of 10 to account for potential inter-species and of 10 to account for intra-species variability will be included in the risk characterisation. Therefore, assessment factors of 100 will be applied to both occupational and consumer exposure scenarios.



Route to Route Extrapolation

There are no long-term dermal or inhalation studies available for systemic toxicity. However, the toxicokinetics studies indicate that there does not appear to be significant first-pass metabolism, so that similar toxicokinetic and toxicodynamic profiles for bendiocarb would be expected after oral, dermal and inhalation exposures. Hence, oral to dermal and oral to inhalation extrapolation for systemic effects is considered to be valid for the risk characterisation of long-term repeated dermal and repeated inhalation exposure scenarios.

For short and medium term inhalation exposure scenarios, a NOAEL from a 13-week rat inhalation study is used. Although, a 21-day dermal study is available in rats, there is no information regarding the dermal absorption of bendiocarb through rabbit skin and so a systemic dose level following dermal exposure cannot be established for use in the risk characterisation. Therefore, oral to dermal extrapolation for systemic effects is considered to be valid for the risk characterisation of short- and medium-term dermal exposure scenarios.

Dose-response/severity of key health effect

There are 3 key repeat-dose studies that will be used in the risk characterisation. These comprise a 13-week rat study for acute and medium-term inhalation scenarios, a 112-day dog study for acute and medium-term oral and dermal exposure scenarios and a two-year dog study for long-term exposure scenarios (by all routes).

In the 112-day oral dog study, the NOAEL of 1 mg kg bw-1 d-1 was based on inhibitions in brain cholinesterase activity that were observed at 112 days. The inhibitions in brain cholinesterase activity were dose-related, with no treatment-related effects occurring at 0.2 mg kg bw-1 d-1, a 10 % reduction (considered to be within normal limits) at 1 mg kg bw-1 d-1, and reductions of 28 % to 42 % in females and males, respectively, at 6.25 mg kg bw-1 d-1. These toxic effects were reversible within two to three days.

In the two-year oral dog study, an inhibition in brain cholinesterase activity was the key health effect and was used to set a NOAEL of 0.65 mg kg bw-1 d-1. At 0.65 mg kg bw-1 d-1 no adverse effects occurred; at 3.12 mg kg-1 d-1 (the LOAEL) there was a 20 % decrease in brain cholinesterase activity at 104 weeks; and at 16.24 mg kg bw-1 d-1 there were 26 % and 34 % reductions in brain cholinesterase activity at 52 and 104 weeks, respectively. No treatment-related clinical signs or mortalities were associated with these changes.

The key health effect in the 13-week inhalation rat study was a reduction in brain cholinesterase activity at 13 weeks, which resulted in the determination of a NOAEC of 2.0 mg m-3. Signs of toxicity were only detected in the high-dose group (20 mg m-3), with reductions of 22 % to 26 % in brain cholinesterase activity in females and males, respectively. An additional observation in this group was an increased incidence in the aggregations of alveolar macrophages in the lungs of males (6/10 for subpleural aggregations, 4/10 for lung parenchymal aggregations).

In addition to the inhibitions of brain and erythrocyte cholinesterase that were observed in the repeat-dose studies, bendiocarb caused acute toxicity by the oral (several laboratory animal



species), dermal (rat) and inhalation (rat) routes. In rats that received a single oral dose of bendiocarb, clinical signs were observed from 1.5 mg kg bw-1 and deaths from 17.7 mg kg bw-1 (LD50 values of 25-156 mg kg bw-1 in males and 27-40 mg kg bw-1 in females were obtained). In dermal studies on rats, toxic effects occurred at 400 mg kg bw-1 and 800 mg kg bw-1 and deaths at 800 mg kg bw-1 (LD50 values of 566-800 mg kg bw-1 d-1). In a single acute inhalation study, clinical signs of toxicity occurred from 0.248 mg l-1 and deaths from 0.377 mg l-1 (LC50 of 0.55 mg l-1, equivalent to 550 mg m-3).

2.2.1.2. Exposure assessment

The active substance is manufactured outside the EU. As there is no direct contact with technical bendiocarb within the EU during its manufacture the exposure from its manufacture has not been addressed.

In the EU, potential exposure to the substance will occur through manufacture and repackaging of the product and during its use. Exposure assessments for manufacturing, repackaging and use of Ficam W are outlined below:

a) Manufacture and repackaging of Ficam W (containing bendiocarb)

The product, Ficam W, is formulated infrequently within the EU and repackaged at a second site within the EU. Due to the automated and closed system employed plus the effective personal protective equipment worn by production workers, neither inhalation nor dermal exposures are expected for both manufacture and repackaging of Ficam W. Oral exposures are also not expected, as both processes should follow the principles of good occupational hygiene practice.

An occupational medical surveillance report for Ficam W production did not reveal any unwanted effects in the workers, apart from skin itches. Between 2000 and 2005, there was one case of intoxication with the worker feeling unwell for a few hours. The worker’s cholinesterase rate (plasma and red blood cell cholinesterase activity) had decreased but was normal again after one day.

b) Use of Ficam W (containing bendiocarb)

Exposure assessments have been carried out on one representative product, Ficam W. Ficam W is a concentrate product (supplied as a powder either within 500 g HDPE containers or water-soluble sachets) that is diluted in water and then applied by knapsack sprayer by the professional operator. Primary and secondary exposure assessments have been undertaken in accordance with the general principles of exposure assessment using a tiered approach (TNsG, June 2002). Initially, a worst-case (Tier 1) assessment is undertaken with, if necessary, further refinement using additional data if the outcome of the worst-case assessment indicates concern.

Primary professional exposure For the primary exposure for professional operators mixing/loading and applying the bendiocarb product, exposure assessment is undertaken using the following Tiers:



(i) Tier 1 - In this assessment it is assumed that there is 5 % penetration of bendiocarb through the skin, 100 % absorption of bendiocarb via inhalation, that no PPE other than gloves are worn, and there is 6 h exposure during mixing/loading and application of the product.

(ii) Tier 2 assessments:

Tier 2a - The Tier 1 assessment is refined by considering that mixing/loading and application of bendiocarb is unlikely to occur more than 2 h per day and protection is afforded by PPE (gloves, coveralls (default protection = 20 %) and eye/face protection). Tier 2b – The Tier 2a assessment is refined to take account of the protection afforded by impermeable coveralls (default protection = 5 %). Tier 2c – The 2b assessment is further refined to take account of additional protection afforded by respiratory protective equipment (10-fold protection factor). Secondary exposure No direct contact with the undiluted Ficam W should occur as it is only to be used by professional operators. However, there is a potential for occupants (humans and companion animals) of treated premises to be exposed via the dermal, oral and/or inhalation routes through contact with the product’s residues after application. The following potential secondary exposure scenarios, and tiered assessments, from the professional use of Ficam W are considered:

Dermal exposure

(i) Scenario 1, Tier 1 - Following application, infant, child or adult comes into hand contact with bendiocarb dislodged from smooth, hard, treated surfaces. Using published information, it is assumed 2 % of the applied product contaminates 40 % of the area of the palm of the hand; the dermal penetration for bendiocarb being 5 %.

(ii) Scenario 2 – Following application, an infant contacts a treated carpet, before and after vacuuming, the following tiered assessments are undertaken.

Tier 1 – The total body area of infant contacts the carpet and, using the default value, 9 % of the carpet residue transfers to the skin; the dermal penetration value for bendiocarb is 5%.

Tier 2a – Tier 1 assessment is refined using data from studies that measured the highest residues on treated carpets before and after vacuuming.

Tier 2b – Tier 2a assessment is refined taking into account the intensity of body contact with the treated carpet and using data from studies that measured the highest mean residue on treated carpets before and after vacuuming.

(iii) Scenario 3 – An infant, child or adult comes into contact with bendiocarb residues while sleeping on a mattress that has been treated to control bedbugs.



Tier 1 – The total body area of an infant, child and adult contacts the treated mattress. The default value for transfer of bendiocarb residue from mattress to skin is 9 % and the dermal penetration value of bendiocarb is 5 %.

Tier 2a – The Tier 1 assessment is refined using data from studies that measured transfer of residue from treated soft furnishings (un-vacuumed carpet) to skin.

Tier 2b – Tier 2a assessment is refined by assuming that the treated mattress is covered by a sheet before persons sleep on the mattress; the transfer of bendiocarb residue from treated mattress through the cover sheet to skin being 10 %.

(iv) Scenario 4 – Adult launders contaminated work clothing at home.

Tier 1 – It is assumed that the residues on the operator’s coverall resulted from 6 hours exposure during mixing/loading and application of the product.

Tier 2 – The Tier 1 assessment is refined by assuming the residues on the operator’s coverall resulted, more realistically, from 2 hours exposure during mixing/loading and application of the product. Oral exposure

(i) Scenario 5, Tier 1 – In this assessment, an infant’s hands come into contact with bendiocarb residue dislodged from treated carpet and ingests residues from the contaminated hands. The assessment uses data from studies that measured the highest mean residue on treated carpets before and after vacuuming.

(ii) Scenario 6 – In the assessment for a companion animal, it is assumed a kitten ingests residue from a treated carpet or other surface, either directly by licking the carpet/surface or through grooming of its fur. Using a reverse reference scenario, the area of treated carpet a kitten would need to contact to achieve the NOAEL is calculated.

Tier 1 – The assessment undertaken assumes all the bendiocarb applied to a carpet is dislodgeable.

Tier 2 – Tier 1 is refined using data from studies that measured highest residues on treated carpets before and after vacuuming.

Inhalation exposure

(i) Scenario 7 – Infant, child or adult exposed to bendiocarb dislodged from treated carpet during and immediately after vacuuming.

Tier 1 – In this assessment, data from studies that measured the highest mean values for bendiocarb residues dislodged from a treated carpet during vacuuming are used as the potential concentration of bendiocarb in the air.



Tier 2 – For a more realistic assessment, the highest mean values measured in the study for bendiocarb residues dislodged from a treated carpet after vacuuming were used as the potential concentration of bendiocarb in the air.

Bendiocarb should not volatilise from treated surfaces under normal conditions of use and therefore should not pose an inhalation hazard to occupants of treated premises; therefore, an exposure assessment via this route of exposure has not been carried out.

In the risk assessments the primary and secondary exposure scenarios considered for the use of Ficam W are:

1. Primary exposure

a. long-term exposure for a professional operator mixing and loading of Ficam W from a 500 g HDPE container into a 5 l knapsack sprayer and then applying the diluted product.

b. long-term exposure for a professional operator spraying diluted Ficam W from a

5 l knapsack sprayer. Exposure from mixing and loading is considered in this scenario to be minimal as the product is supplied in water-soluble sachets.

The primary exposure assessments (Tier 2c) for use in the risk assessment are summarised in Table 2.1 and have been compared with a NOAEL of 0.65 mg kg bw-1 d-1 from a two-year dietary study in dogs is used, based on toxicologically significant inhibitions in brain cholinesterase activity.

Table 2.1 Summary of the exposure scenario for use in the risk assessment

Ficam W (containing bendiocarb)

Tier Default values Systemic exposure

(mg kg bw-1 d-1)

HDPE Container – mixing and loading then spraying

2c 60 kg adult; 2 hours a day; 5 % dermal penetration; 100 fold assessment factor; PPE: impermeable coveralls, gloves, eye/face protection, RPE (10-fold protection factor).

0.0049

Water-soluble sachets – mixing and loading then spraying

2c <0.0049

2. Secondary exposure

1. acute/medium-term and long-term dermal exposure – following application,

infant, child or adult comes into contact with bendiocarb dislodged from smooth, hard, treated surfaces;

2. acute/medium-term and long-term dermal exposure – infant contacts treated soft



furnishings (e.g. a carpet), before and after vacuuming; 3. acute/medium-term and long-term dermal exposure – infant, child or adult

comes into contact with bendiocarb while sleeping on a mattress that has been treated for bedbugs;

4. acute/medium-term and long-term dermal exposure – adult launders contaminated work clothing at home;

5. acute/medium-term and long-term oral exposure - infant comes into contact with bendiocarb residue dislodged from smooth, hard, treated surfaces and ingests the residue;

6. acute/medium-term oral exposure – kitten ingests residue from treated carpet or other surface, either directly from licking the carpet/surface or through grooming, i.e. by removing from the fur residue that has been dislodged from the carpet, and

7. acute/medium-term and long-term inhalation exposure – infant, child or adult exposed to bendiocarb dislodged from treated carpet during and immediately after vacuuming.

The risk assessments are based on the particular tiered assessments for secondary exposure, which are summarised in Table 2.2. The exposures have been compared with a NOAEL of 0.65 mg/kg bw/d from a two-year dietary study in dogs for long-term oral and dermal exposure scenarios, a NOAEL of 1.0 mg/kg bw/d from a 112-day oral dog study for acute/medium-term oral and dermal exposure scenarios and a NOAEC of 2 mg m-3 (equivalent to a systemic dose of 0.6 mg/kg bw/d) inhalation exposure scenarios. A NOAEL of 0.5 mg pure bendiocarb/kg bw from a single oral administration study in cats has been used in the assessment for companion animals.

Table 2.2 Summary of the exposure scenarios for use in the risk assessment

Exposure route

Scenario Tier Default values Systemic exposure

(mg/kg bw/d) Dermal Adult, child and

infant come into contact with smooth, treated surfaces

1 acute/

medium-/ long-term

60 kg adult, 34.4 kg child and 10 kg infant; 2 % dislodgeable residues to 40 % palm; 5 % dermal penetration; 100-fold assessment factor

0.00004(I) 0.000036(C) 0.000028(A)

Infant exposed to soft furnishings post application, before and after vacuuming.

2a acute/

medium-term

10 kg infant; 5 % dermal penetration; 100 % skin contact; 100-fold assessment factor.

0.0083(BV) 0.0007 (AV)

2b long-term

10 kg infant; 5 % dermal penetration; 100 % skin contact; transfer coefficient 6000 cm2/h; 100-fold assessment factor.

0.0042 (BV) 0.0005 (AV)

Infant, child or adult sleeps on

2a acute/

60 kg adult, 34.4 kg child and 10 kg infant; 9 % transfer from

0.0045(I) 0.0024(C)



treated mattress medium/ long-term

mattress to skin; 5 % dermal penetration; 100- fold assessment factor

0.0024(A)

Adult launders contaminated clothing

1 acute/

medium/ long-term

60 kg adult; 30 % material contaminates hand; 5 % dermal penetration; product used 6 hours per day 5 days a week; 100-fold assessment factor.

0.0038

Oral Infant contaminates hands and there is hand to mouth transfer

1 acute/

medium/ long-term

10 kg infant; 100 % transfer and 100 % oral absorption; 100-fold assessment factor.

0.0006(BV) 0.00006(AV)

Kitten ingests bendiocarb from treated carpet.

2 long-term

Reverse reference scenario to determine how much pure bendiocarb would need to be ingested from a treated carpet by a 0.5 kg kitten to achieve the NOAEL.

961.5 cm2 (BV)

11363.6 cm2 (AV)

Inhalation Infant, child and adult exposed to bendiocarb during vacuuming.

1 acute/

medium- term

60 kg adult, 34.4 kg child and 10 kg infant; exposure to 0.0137 mg bendiocarb/m3 for 24h 100-fold assessment factor

0.0062(I) 0.0056(C) 0.0035(A)

2 long-term

60 kg adult, 34.4 kg child and 10 kg infant; exposure to 0.0137 mg bendiocarb/m3 for 0.5 h during vacuuming; exposure to 0.0036 mg bendiocarb/m3 for 23.5 h after vacuuming 100-fold assessment factor

0.00013(I;DV) 0.0001(C;DV) 0.00007(A;DV) 0.0016(I;AV) 0.0015(C;AV) 0.0009(A;AV)

I = infant C = Child A = adult BV = before vacuuming DV = during vacuuming AV = after vacuuming

3. Combined exposures

a. long term exposure – adult and child exposed to bendiocarb from dislodgeable residues via the inhalation and dermal routes and through laundering of clothing (adult only);

b. infrequent exposure – adult exposed to bendiocarb from dislodgeable residues via the inhalation and dermal routes, through laundering of clothing, mixing/loading from HDPE containers and spraying the in-use product;

c. infrequent exposures – adult exposed to bendiocarb from dislodgeable residues via the inhalation and dermal routes, through laundering of clothing, mixing/loading from sachets and spraying the in-use product;

d. long-term exposure – infant could come into contact with dislodgeable residues from the dermal and inhalation routes.



The combined exposure assessments (Tier 1 and 2) for use in the risk assessment are summarised in Table 2.3 and have been compared with a NOAEL of 0.65 mg kg bw-1 d-1 from a two-year dietary study in dogs for long-term exposure. For those infrequent events a NOAEL of 1.0 mg kg bw-1 d-1 from a 112-day oral dog study has been used.

Table 2.3 Summary of exposure scenarios for use in the risk assessment

Scenario Systemic exposure (mg/kg bw/d) Infant Child Adult

Adult and child exposed to dislodgeable residues. Adult

laundering of clothing.

N/A 0.0015 0.0022

Adult exposed following mixing/loading from HDPE

containers, spraying and dislodgeable residues

N/A N/A 0.0071

Adult exposed following mixing/loading from sachets,

spraying and dislodgeable residues

N/A N/A 0.005

Infant exposed to dislodgeable residues

0.0022 N/A N/A

2.2.1.3. Risk characterisation

Primary exposure

Technical bendiocarb is produced outside the EU. Consequently, no human health exposure scenarios have been assessed for the manufacture of the active substance.

Ficam W is formulated and packaged in the EU. Due to the automated and closed system employed, the effective personal protective equipment worn by production workers and the ventilated semi-open system, neither inhalation nor dermal exposure is expected for people involved in the production or the re-packaging of Ficam W.

The Tier 2b assessment of the mixing/loading and application of Ficam W dispensed as a wettable powder from the HDPE container gives an MOE of 45, indicating that the risks to human health are unacceptable. Refinement of the assessment (by inclusion of RPE) for Tier 2c gives an MOE of 133, indicating that the risks to human health under these conditions are acceptable. Exposure solely from handling and undertaking mixing/loading operations using the sachets would be negligible compared to decanting Ficam W from the 500 g HDPE containers. Thus, the Tier 2c MOE for mixing/loading the sachets and applying the in-use concentration spray would be greater than 133.



Secondary exposure

Dermal The risks from secondary exposure to Ficam W (containing bendiocarb) through the dermal route have been assessed in a range of relevant exposure scenarios. The risks from exposure to adults, children and infants at the Tier 1 or 2 level (MOEs >144), assuming a dermal penetration of 5 %, are considered to be low. Oral As infants and companion animals are considered to be the only groups that are likely to be orally exposed to residues dislodged from treated surfaces, the risk assessment for oral exposure only focuses on these groups. In the Tier 1 assessment the acute/medium-term and long-term risks from an infant consuming the product even without vacuuming of treated surfaces are considered to be low; MOE = 1667 (acute/medium-term) and 1083 (long-term). In a Tier 2 assessment, a kitten would need to ingest all transferable residues from 961.5 cm2 and 11,363 cm2 of treated carpet before and after vacuuming, respectively, to achieve a body burden equivalent to the systemic NOAEL for short-term exposure. The risks to infants and companion animals from oral exposure to Ficam W (containing bendiocarb) are considered to be low. Inhalation The risks from acute/medium-term and long-term inhalation exposure to bendiocarb are considered to be acceptable. MOEs for exposure to bendiocarb dislodged from a treated carpet during vacuuming for infant, child and adult are 4615, 6000 and 8571; MOEs immediately after vacuuming are 375, 400 and 667. Therefore, Ficam W (containing bendiocarb) does not present a risk via inhalation in this scenario to adults, children and infants. According to Curry et al (1995) a substance should only be considered volatile if it has a vapour pressure >10 mPa at 20 0C. As the vapour pressure of bendiocarb is 1.9 mPa at 20 oC, it is not considered to be volatile. It is considered that Ficam W (containing bendiocarb) does not present a risk to human health via inhalation. Combined exposure Except for those exposures during application of the product, the greatest contribution to the exposures is from the inhalation of residue dislodged from a treated carpet. This is a worse-case assessment as the scenario assumes that the air concentrations would persist over the long



term. In reality, air levels would be expected to decline because of settlement of particles, natural ventilation of the treated premises and the progressive reduction of bendiocarb in the carpet by repeated vacuuming. The exposure to airborne bendiocarb would be expected to be transient. Because only relatively long-term NOAELs are available for the risk assessment MOEs for exposure by inhalation are excessively conservative. It is therefore considered that the combined exposures to bendiocarb are unlikely to present an unacceptable risk to humans given the intended pattern of use.

2.2.2. Environmental Risk Assessment

2.2.2.1. Fate and distribution in the environment

Fate in the aquatic compartment

Bendiocarb has been shown to hydrolyse at a moderate rate under environmental temperatures and pH with a predicted DT50 of 5.7 d (at 12 °C and pH 7). At pH 7, a major hydrolysis product, NC 7312 was identified, which was recorded as reaching 87.9 % of the applied parent compound under the conditions tested (25 °C). Photolysis was shown to be only a minor route of removal of bendiocarb, with a DT50 of 187 d predicted from the available data after adjustment for natural sunlight.

Based on the data provided, bendiocarb was not shown to be readily biodegradable, but did undergo biodegradation (DT50 17.1 d at 12 °C, k = 0.041 d-1) to a single major metabolite, NC 7312, which further degraded to CO2 in aerobic sediment/water systems. NC 7312 was shown to reach a maximum mean level of 28 – 32 % applied radioactivity (AR) in the water phase after 7 d and 17 - 18 % AR in the sediment after 2 – 3 d. 14CO2 was shown to range from 20 – 36 % in water and <0.1 – 23.6 % as bound residues. The rate of degradation of the metabolite was shown to be enhanced in the presence of sediment, with DT50s between 22.6 d (sediment-water system) and 132.8 d (filtered water) calculated for 12 °C. Degradation of bendiocarb under anaerobic conditions was shown to follow the same route as under aerobic conditions but at a slightly higher rate (DT50 8.9 d adjusted to 12 ºC). Degradation of the major metabolite, NC 7312, was not investigated further in the anaerobic system.

Data were submitted that demonstrated that bendiocarb has a low potential to bioconcentrate and hence bioaccumulate in fish with a bioconcentration factor (BCF) of 6.0 found for the whole body of the fish. These findings are further supported by the results from calculating a BCF using a QSAR from the ‘Technical Guidance Document on Risk Assessment in support of Commission Directive 93/67/EEC (new notified substances), Commission Regulation (EC) No 1499/94 (existing substances) and Directive 98/8/EC (biocidal products)’ (EC, 2003). This returned a value of 5.55, which agrees very closely with the study results.

Fate in air

The fate of bendiocarb in air was investigated using the quantitative structure activity relationship estimation method (QSAR; TGD, 2003), which considers the reaction with the daily air concentrations of hydroxyl (OH) radicals. A maximum estimated half-life of 13.2 h was predicted but as the active substance is not considered volatile, as shown by the reported



vapour pressure of 1.9 mPa (at 20 ºC), the air compartment is not considered further within the following exposure assessment.

Fate in the terrestrial compartment

A study of the effect of sunlight on a soil surface indicated that bendiocarb could undergo rapid photolysis, with a DT50 of 1.4 d assuming a temperature of 12 ºC. The major photolysis products were shown to be strongly bound to the soil and not readily extracted.

Biodegradation of bendiocarb was investigated under aerobic conditions in 3 soils (a sandy loam, a silty clay loam and sand (< 1. organic matter)) and was shown to be reasonably rapid with DT50s of between 2.1 and 9.9 (when adjusted to 12 ºC). However, the degradation end-points from the sand soil have been discounted, as this does not represent the normal range of soils. Therefore, the DT50 of 9.9 d is considered an appropriate worst-case value for use in an environmental risk assessment for refinement of exposure values where applicable.

The route of degradation in soil was shown to be similar to that in water-sediment studies with the formation of the metabolite NC 7312 followed by unextractable residues (~ 45 % applied radioactivity [AR]) and carbon dioxide (~ 55 % AR) by the end of the test (26 weeks). However, the known metabolite, NC 7312 degraded rapidly in soil and was only reported to exceed 10 % AR in sand, which was used primarily to explore the effect of volatility on the test. Therefore, it has been assumed that whilst degradation of bendiocarb in soil will occur, the known metabolite NC 7312 will not trigger a level of concern for soil compartment under the proposed use patterns.

The adsorption and desorption of bendiocarb has been shown to be influenced by the organic content of the soil matrix. The arithmetic mean Koc value of 33.65 l kg-1 suggests that bendiocarb would not adsorb strongly to soil and would very easily undergo desorption, suggesting a potential for high mobility in the soil compartment. The known metabolite (NC 7312) has an estimated Koc of 202.5 l kg-1, which suggests that this substance (formed at < 10 % applied parent in the laboratory) would have a tendency to be mobile in soil.

Overall, the available fate and behaviour studies suggest that bendiocarb would be subject to removal from the soil compartment as a result of degradation to NC 7312, pyrogallol, bound residues and subsequent mineralisation to CO2. The parent and main metabolite, NC 7312 would also be subject to mobility pressures, which would further remove any residues from this compartment. Therefore, the overall fate profile for this compound suggests that even if repeated exposures of the soil compartment were to occur, it is unlikely that accumulation in this compartment would take place.

2.2.2.2. Effects assessment

In the aquatic compartment, the species most sensitive to bendiocarb was shown to be the water flea (Daphnia magna) following both acute and chronic exposure with a 21 d NOEC, based on reproduction, length and weight, of 0.88 µg l-1. This result is consistent with the view that invertebrates are usually more sensitive than fish or algae to insecticidal active substances.



Therefore, in consultation with the TGD, an assessment factor of 10 is considered appropriate and a PNEC of 0.088 µg l-1 has been used for risk assessment.

NC 7312 shows considerably lower aquatic toxicity than bendiocarb, and even though only the base set acute data are available and an assessment factor of 1000 was used, the derived PNEC of 10 µg l-1 is 100 times higher than that of the parent.

A PNEC for the sediment compartment for neither the parent nor metabolite has been derived because the trigger values for a sediment assessment, as given by the TGD (Koc > 500 l kg-1

and/or log Kow > 3), were not reached for bendiocarb (mean 35.65, and 1.7 respectively). As for NC 7312, whilst the log Kow is 3.15, the predicted Koc is 202.5 l kg-1, which suggests that a sediment assessment should not be performed. Furthermore, the fate of bendiocarb and NC 7312 in sediment-water systems suggested that both substances tended to be associated predominantly with the water phase.

For the effects assessment of the soil compartment, endpoints are available for bendiocarb from an acute earthworm (Eisenia fetida) study with an LC50 (14 d) of 188 mg a.s. kg-1 dw reported in addition to a series of chronic soil microorganisms that suggest the NOEC for bendiocarb of 50 mg kg dw and is appropriate for the limited soil exposures being considered. As only one chronic terrestrial study is available (a NOEC derived from a test with limited exposure of soil micro-organisms) and no plant data have been submitted, a precautionary approach has been taken, which is to use an assessment factor of 1000 instead of 100 as recommended by the TGD (Table 20) to give a PNEC of 0.19 mg a.s kg-1 dw soil.

NC 7312 was not shown to be a metabolite of concern in all but sand soils. Sand soils are not considered to represent average soil conditions and were only used in the study to investigate the volatility of bendiocarb from a soil surface.

2.2.2.3. PBT assessment

According to the TGD, ‘The Persistent, Bioaccumulative and Toxic (PBT) assessment is considered to be different from the local and regional assessments approaches, as it seeks to protect ecosystems where risks are more difficult to estimate’. Under the Biocidal Products Directive (BPD), a PBT assessment is needed to demonstrate that a substance does not fulfil selection under the United Nations Environment Programme – Persistent Organic Pollutants convention (UNEP-POPs) to limit emissions to the environment of those chemicals with high potential for persistence, bioaccumulation, long-range transport and adverse effects on human health and the environment. Any substance that is found to be either a PBT or very Persistent very Bioaccumulative (vPvB) substance shall not be allowed on Annex I unless releases to the environment can be effectively prevented.

Persistence

Data have been presented, which show that bendiocarb did degrade reasonably rapidly in the aquatic environment with a worst-case DT50 value of 17.1 d at 12 °C under aerobic conditions in a sediment/water system. Therefore, bendiocarb does not fulfil the criteria for a persistent compound according to the TGD (> 40 d in freshwater and/or > 120 d in freshwater sediment).



The rate of degradation of the major metabolite, NC 7312, was shown to be enhanced in the presence of sediment, with a DT50s of 22.6 d (sediment-water system) to 132.8 d (filtered water) reported at 12 °C. Therefore, this metabolite is not considered to be of concern with regard to persistence in the aquatic environment and need not be considered further.

Bioaccumulation

A substance is considered to have the potential to fulfil the criterion of bioaccumulation when the log Kow exceeds 4.5, but as a log Kow of 1.7 has been derived for bendiocarb there is no trigger for an assessment of the bioaccumulation potential of this active substance in aquatic organisms. Therefore, the bioaccumulation criterion is not fulfilled.

Toxic

According to the available data, the most sensitive chronic endpoint for bendiocarb is that derived for a 21 d Daphnia study (NOEC of 0.88 µg l-1). This means that the trigger of < 0.01 mg l-1 given in the TGD is exceeded and bendiocarb can be considered to have fulfilled the criterion for toxic.

No data on the effects against birds have been submitted (or are considered necessary) for this assessment.

As bendiocarb has only fulfilled one criterion (T) out of the 3 considered, it can be accepted that it is not a PBT substance.

2.2.2.4. Exposure assessment

The environmental exposure assessment for bendiocarb has been produced using all available information. This has been taken from submitted studies and the Organisation for Economic Co-operation and Development (OECD) Task Force document; 5th Draft Emission Scenario Document (ESD) for ‘Insecticides, acaricides and products to control arthropods (PT 18) for household and professional use’ (OECD, July 2008). Information and guidance was also taken from part II of the Technical Guidance Document on risk assessment (TGD; EC, 2003). Furthermore, information and decisions taken from TM I and III 9 regarding modifications to building size and number, along with application rates to crack and crevice areas have been taken into account. All calculations within the exposure scenario apply to bendiocarb only, as other constituents of the Ficam W product formulation are not considered to be compounds of concern. With regard to metabolites, NC 7312 is only considered as a major metabolite (of concern) in the aquatic compartment. A full list of input parameters for PEC values is seen in Table 2.4.



Table 2.4 PEC input assumptions

Input/Parameter (units) Data/Endpoint Local population in catchment of STP (-) 10,000 Daily wastewater flow per inhabitant (l d-1 eq-1) 200 Effluent discharge rate of STP (l d-1) 2 x 106

Population per house (-) 2.49 Average number of rooms per house (including bathroom) 6.46 Size of domestic household (m²) 131 Size of large building (m²) 609 Default wet cleaned area per household (m2) 38.5

Default wet cleaned area per large building (m2) 180

Number of potential houses treated per catchment 4000 (indoor) 2500 (outdoor)

Number of potential large buildings treated per catchment 300 (indoor) 300 (outdoor)

Simultaneity Factor (%) 0.82 (indoor) 0.2 (outdoor)

Realistic maximum spray band width (m) 0.5 (outdoor) 0.1 (indoor)

Maximum % exposed to cleaning – Spray (crack and crevice) 15 Cleaning efficacy – Spray (crack and crevice) 0.15 Fraction to water 0.99 Soil volume exposed per domestic property (m3) 2.8 Area of soil around a single domestic property that may be contaminated after application (m2)

28

Soil volume exposed per large building (m3) 5.28 Area of soil around a single large building that may be contaminated after application (m2)

52.8

Spray drift from treated to untreated area (%) 0.42

Amount of applied active lost to soil/drains during 1st rain event (%) 50

The environmental exposure assessment for Ficam W (a wettable powder formulation that contains 80 % pure bendiocarb w/w) is based on use by professionals only, for both indoor and outdoors treatments using an application rate of 96 mg pure bendiocarb m-2. The potential environmental releases of bendiocarb resulting from the use of Ficam W will largely depend on the target pest being treated. For example, indoor infestations of cockroaches/ants will be largely associated with hard surface treatment limited to food preparation areas i.e. kitchens, whereas flea infestations are more likely to occur throughout the house where carpeted areas or pet bedding exist. Treatments to upholstered and soft furnished areas for fleas are assumed to be vacuumed or dry cleaned and not subject to frequent wet cleaning. Therefore, residues from this type of treatment are expected to go to landfill, with negligible emissions to drains. Outdoors, treatments against pests such as ants are considered to be the most common use for Ficam W, with treatment of wasp and wild bee nests occurring less frequently.



The environmental emissions associated with the local scale are considered to present the worst-case scenario in terms of predicted environment concentrations (PECs). The use patterns have been considered separately in terms of domestic and large buildings for indoor and outdoor applications to avoid an excessive or over-prediction of exposure of the wider environmental compartments due to the existing worst-case assumptions of the use patterns already present within the scenarios used. In the scenarios presented, the underpinning assumption is that the associated product, Ficam W, is for professional use only and will be used responsibly in such a way as to maximise the effectiveness of the treatment and minimise unnecessary exposure of non-target groups (people, animals and environment). The potential environmental emissions identified are:

Indoor use

Emissions from treated hard surfaces (tiles, laminate, concrete etc) as a result of wet cleaning resulting in:

• Direct exposure to the sewage treatment plant (STP) compartment via drains with,

i. indirect exposure to surface waters (including sediment) via STP effluent,

ii. indirect exposure to soil compartment (including groundwater) via STP sludge application to land and

iii. indirect exposure to biota via surface waters (bioconcentration in fish leading to secondary poisoning of fish eating birds).

Potential emissions from treated soft furnishings (carpets, rugs, furniture etc) as a result of wet cleaning resulting in:

• Direct exposure to the sewage treatment plant (STP) compartment via drains with,

iv. indirect exposure to surface waters (including sediment) via STP effluent,

v. indirect exposure to soil compartment (including groundwater) via STP sludge application to land and

vi. indirect exposure to biota via surface waters (bioconcentration in fish leading to secondary poisoning of fish eating birds).

The UK CA is of the view that this route of entry (wet cleaning of soft furnishings) to the environment is unlikely to contribute to emissions to STP and surface waters. Soft furnished areas tend to be vacuumed, not mopped, with these emissions going to landfill, not into drains. Soft furnished areas are likely to be treated in the case of flea infestation, as this is their preferred habitat. Following the treatment, any shampooing of the carpet would be unlikely and inadvisable, as efficacy against any unhatched eggs would not be maintained.



Outdoor use

1. Emissions from product washed off/from treated surfaces (walls, concrete) as a result of weathering/precipitation resulting in:

• Direct exposure to the STP compartment via surface drains adjacent to treated area,

i. indirect exposure to surface waters (including sediment) via STP effluent (run-off assumed to be negligible),

ii. indirect exposure to soil compartment (including groundwater) via STP sludge application to land and

iii. indirect exposure to biota via surface waters (bioconcentration in fish leading to secondary poisoning of fish eating birds).

• Direct exposure to soil compartment adjacent to treated area, i. indirect exposure to biota via soil (secondary poisoning of worm eating

birds) and ii. indirect exposure to groundwater compartment via soil.

2. Exposure of non-target species to biocidal product used on hard surfaces outdoors resulting in:

i. direct exposure to non-target birds/mammals to biocidal product (primary poisoning) and

ii. indirect exposure to non-target birds/mammals to biocidal product via consumption of target pest (secondary poisoning).

It should be noted that the air compartment is unlikely to be exposed because the available vapour pressure data (vapour pressure for bendiocarb = 1.9 mPa at 20 °C) suggests that this active substance would not be regarded as volatile in the product Ficam W. This is further supported by the fact that the Ficam W product is formulated as a wettable powder. Therefore, it has been concluded that the air compartment is not of concern and no assessment has been presented. Indoor application scenario

The major route of environmental exposure following indoor treatment is considered to be via drains, as a result of wet cleaning of treated hard surfaces; cleaning of this nature is likely to occur as a matter of routine hygiene in both domestic and commercial premises. Treatment of hard surfaces is restricted to professional use, and advice will be given not to clean the treated area until the infestation is under control. Additionally, due to the nature of the target pests, the product should be applied to pest harbourages (cracks, crevices and spot treatments) and to surfaces that are not prone to frequent wet cleaning. Such action will promote efficacy and will also avoid unacceptable environmental and human exposure. In areas of rooms where regular cleaning is essential (such as open floor space) it is unlikely that this type of formulation would be selected by the professional pest controller.

Treatment of soft furnished areas will be carried out indoors by professionals using low pressure coarse sprays to negate drift, so transfer to hard surfaces will be negligible. Bendiocarb’s low vapour pressure will assist in limiting transfer to hard surfaces. Subsequent



carpet cleaning is most likely to be carried out via vacuuming, so exposure to other areas during this cleaning step is not seen as likely or significant. Wet mopping of carpets is impractical and unlikely, so is not considered further. The one potential route to drains following soft furnishing treatment could be via carpet shampooing, but as previously stated, environmental emissions from this route are likely to be very limited. Shampooing of carpets is unlikely as a normal regular practice, and inadvisable soon after treatment from an efficacy standpoint. Householders will be advised by professional operators not to carry out such cleaning for a specified period post-treatment. The length of this period will vary according to the pest species being treated.

Given all of the above, the UKCA considers it reasonable not to consider shampooing and wet mopping of soft furnishings as part of the exposure assessment.

Further to the above, the indirect environmental exposure via domestic/industrial waste disposal to landfill (as a result of dry (vacuum) cleaning) has not been considered in this exposure assessment. This is because this route of exposure is much less likely to be of concern when compared to the direct exposure via the STP compartment. In addition, the effect of its dilution with other wastes, biodegradation of the active substance (a.s.) and the significant containment measures at landfill sites according to European Union (EU) waste regulations (EU Directive 99/31/EC) reduce any concerns further.

The PEC values for the main compartments of concern resulting from the indoor use of Ficam W are presented in the Tables 2.5 – 2.7 below.

Outdoor application scenario The main direct environmental exposure route to be considered following outdoor treatment is to surface waters via STP as a result of run-off to facility drains from hard surfaces. Indirect exposure of the soil compartment adjacent to treated buildings, resulting from run-off, is also considered possible as a result of the use of Ficam W. However, as per the instructions of the Applicant, no direct deliberate application to soil or plants should be allowed to occur; therefore, a full risk assessment of this particular type of use has not been considered. It should be noted that as the active substance is an insecticide, direct application to soil should be avoided to prevent any unnecessary exposure to non-target arthropods. The PEC values for the main compartments of concern resulting from the indoor and outdoor uses of Ficam W are presented in Tables 2.5 – 2.7 below.

Table 2.5 PEC STP

Scenario Indoor PEC (mg l-1) Outdoor PEC(mg l-1) Total PEC (mg l-1) Domestic 4.67 x 10-4 5.69 x 10-4 1.04 x 10-3 Commercial 1.63 x 10-4 1.44 x 10-4 3.07 x 10-4 Both 6.30 x 10-4 7.13 x 10-4 1.35 x 10-3



Table 2.6 PEC SURFACE WATER

Scenario Indoor Outdoor (STP)** Outdoor*

Indoor + Oudoor (STP)**

Indoor + Outdoor*

mg l-1

Bendiocarb

Domestic 4.67 x 10-5 5.69 x 10-5 5.69 x 10-5

1.04 x 10-4 1.04 x 10-4

Domestic (refined) 1.75 x 10-5 2.13 x 10-5 3.88 x 10-5 7.44 x 10-5

Commercial 1.63 x 10-5 1.44 x 10-5 1.44 x 10-5

3.07 x 10-5 3.07 x 10-5

Commercial (refined) 6.11 x 10-6 5.39 x 10-6 1.15 x 10-5 2.05 x 10-5

Total 6.30 x 10-5 7.13 x 10-5 7.15 x 10-5

1.34 x 10-4 1.35 x 10-4

Total (refined) 2.36 x 10-5 2.67 x 10-5 5.03 x 10-5 9.51 x 10-5

NC 7312

Domestic 3.02 x 10-5 3.68 x 10-5 3.68 x 10-5

6.70 x 10-5 6.70 x 10-5


Commercial 1.05 x 10-5 9.30 x 10-6 9.30 x 10-6

1.98 x 10-5 1.98 x 10-5


Total 4.07 x 10-5 4.61 x 10-5 4.62 x 10-5

8.68 x 10-5 8.69 x 10-5

Total (refined) 1.53 x 10-5 1.73 x 10-5 3.26x 10-5 6.15 x 10-5

* Rural outdoor treatment with 100 % run off to surface waters (no hydrolysis or STP)

** Urban outdoor treatment with 100 % run off to STP

Table 2.7 PEC Soil

Scenario PEC wet weight (mg kg-1) PEC dry weight (mg kg-1) Domestic 4.83 x 10-2 5.46 x 10-2 Commercial 4.97 x 10-2 5.62 x 10-2

2.2.2.5. Risk characterisation

Risks to the aquatic compartment

Table 2.8 presents the combined indoor plus outdoor risk characterisation (PEC:PNEC) values for bendiocarb and NC 7312 in surface waters as a result of using the insecticidal product Ficam W in both domestic and commercial situations.



Table 2.8 Combined indoor plus outdoor risk characterisation (PEC:PNEC) values for bendiocarb and NC 7312 in surface waters as a result of using the insecticidal product

Ficam W for both domestic and commercial scenarios

According to the data presented in Table 2.8 above, the proposed use patterns of the insecticide product Ficam W should not pose an unacceptable risk to surface waters when exposed via STP effluent as a result of indoor plus outdoor treatments for either domestic or commercial scenarios. However, when domestic and commercial treatments are combined and under the assumption that all outdoor treatments are directly released into surface waters, the risk of exposure to bendiocarb (not its metabolite) to surface waters is unacceptable, with an unrefined PEC:PNEC ratio of 1.50, and a refined PEC:PNEC ratio of 1.06 (the only available refinement was degradation in water, applied where possible). Further information provided by the Applicant concerning global production tonnages is considered to remove this unacceptable risk. This having been said, from the information presented in Table 2.8 it can be deduced that, in the case of indoor treatment on hard surfaces, an increase in the amount of wet cleaning (or application to areas subject to frequent wet cleaning) could result in an unacceptable risk to surface waters, so the restriction of use to cracks, crevices and spot treatments is appropriate in this case. Good practice would suggest that operators should avoid contamination of surface waters through losses to drains as far as is practicable, although again, it is considered that this unacceptable risk is removed when allowance is made for further information provided by the Applicant concerning global production tonnages.

Scenario

PEC Indoor + Oudoor

(STP) (µg l-1)

PEC Indoor + Outdoor (µg l-1)

PNEC (µg l-1)

PEC:PNEC Indoor + Oudoor (STP)

PEC:PNEC Indoor (STP) +

Outdoor (no STP)

Bendiocarb

Domestic 1.04 x 10-1

1.04 x 10-1

0.09

1.16

1.16

Domestic (refined) 3.88x 10-2 7.44 x 10-2 4.31 x 10-1 8.27 x 10-1

Commercial 3.07 x 10-2 3.07x 10-2 3.41 x 10-1 3.41 x 10-1


Total 1.34 x 10-1

1.35 x 10-1

1.49

1.50

Total (refined) 5.03 x 10-2 9.51 x 10-2 5.59 x 10-1 1.06

NC 7312

Domestic 6.70 x 10-2 6.70 x 10-2

10.0

6.70 x 10-3 6.70 x 10-3


Commercial 1.98 x 10-2 1.98x 10-2 1.98 x 10-3 1.98x 10-3


Total 8.68 x 10-2 8.69 x 10-2 8.68 x 10-3 8.69 x 10-3

Total (refined) 3.26 x 10-2 6.15 x 10-2 3.26 x 10-3 6.15 x 10-3



No PEC-PNECsediment values have been determined for bendiocarb or its major metabolite (NC 7312) as it was concluded that neither pose any significant threat to the sediment compartment. Bendiocarb has a low log Kow of 1.7, a mean Koc of 33.65 l kg-1 and was shown to remain predominantly in the water phase of a water-sediment environment. Despite a log Kow of 3.15 being at the trigger point for concern, a predicted Koc of 202.5 l kg-1 (QSAR) and sediment-water results (maximum of 32 % in water after 7 d, maximum of 18 % in sediment after 3 d) suggests that NC 7312 would also be predominantly associated with the aqueous phase and not sediment.

Risks to the soil compartment

From the proposed use pattern for Ficam W there are two areas to consider regarding the risks to soil as follows:

• the risks to the local or adjacent soil compartment from the outdoor use of the product (assuming 50 % emission from a single annual application of Ficam W used outdoors, and following photodegradation) as a result of a weathering event; and

• the risks to soil from applied sewage sludge containing bendiocarb as a result of losses to drains from either indoor or outdoor use.

The available risk characterisation data (see Tables 2.9 and 2.10) show that the use of bendiocarb as an insecticide in Ficam W, according to the proposed use pattern for this product, does not pose an unacceptable risk to any soil compartment.

Table 2.9 Risk characterisation (PEC:PNEC) values for bendiocarb in the soil compartment as a result of using the insecticidal product Ficam W

Scenario PEC (mg kg-1 dw)

PNEC (mg kg-1 dw)

PEC:PNEC

Domestic 5.46 x 10-2 0.19

2.87 x 10-1 Commercial 5.62 x 10-2 2.96 x 10-1

Table 2.10 Risk characterisation (PEC:PNEC) for bendiocarb resulting from the application of sewage sludge to local and agricultural soils from the use of Ficam W

Scenario PEClocalsoil/agr.soil

(mg kg-1 dw) PNEC

(mg kg-1 dw) PEC:PNEC

Outdoor treatment (worst-case)

2.98 x 10-5 0.19 1.57 x 10-4

In soil bendiocarb has the potential to be mobile (Koc 33.65 l kg-1) and been shown to metabolise via the known metabolite, NC 7312, which in turn forms bound residues in the soil compartment and eventually mineralises to CO2. Whilst it is reasonable to assume that bendiocarb would move beyond the 10 cm depth, according to a PEARL assessment, neither bendiocarb nor NC 7312 would be expected to pose a significant risk to groundwater when applied to the perimeters of domestic buildings.



Risks to non-target biota

From the proposed use pattern and formulation the only non-target biota considered to be at potential risk from the use of bendiocarb in Ficam W are honey bees. It can be accepted that exposure of these organisms would result in a toxic response, particularly as the product is sold for use against wasp and wild bees. However, as the product is restricted to professional users appropriate risk mitigation measures via labelling is proposed: ‘where relevant, action should be taken to prevent foraging bees gaining access to the treated nest, preferably by removing the combs or blocking the nest entrances’.

Risks for other non-targets such as birds and small mammals have not been considered because of the formulation and application type. Therefore, changes to the formulation may trigger the need for additional data and risk assessment to assess this risk at Member State level.

2.2.3. List of endpoints

In order to facilitate the work of Member States in granting or reviewing authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and the common principles laid down in Annex VI of that Directive, the most important endpoints, as identified during the evaluation process, are listed in Appendix I.

3. DECISION

3.1. Background to the Decision

This Review of the active substance bendiocarb has covered Product Type 18 (Insecticides, acaricides and to control other arthropods), professional use only, against cockroaches, ants, fleas, flies, stored product pests, bed bugs, carpet pests, wasps, wild bees, silverfish and other bristle tails, ground beetles, earwigs, crickets, booklice, spiders and woodlice.

The human health risk assessment indicates that the risks from primary exposure to bendiocarb are acceptable when appropriate and suitable PPE is employed. The major risks from exposure to bendiocarb are to the person carrying out the bendiocarb treatment. It is considered that the assessments for primary exposure are likely to be highly conservative as they are based on a person carrying out a bendiocarb treatment every day for their working life, which is unlikely to occur as the majority of professional treatments with bendiocarb will occur in the summer months to treat insect problems. In addition the NOAEL on which the assessments are based is taken from a 2-year dog study in which no severe toxicity was noted at dose levels higher than the NOAEL. The assessments on which the risks are identified require the operator to wear appropriate and suitable PPE (including RPE) when using Ficam W and this should be a requirement of its use (section 3.3).

The human health risk assessment indicates that the risks from secondary exposure to bendiocarb are acceptable. The greatest risk from secondary exposure to bendiocarb is from the inhalation of residue dislodged by vacuuming a treated carpet. However, this risk assessment is



excessively conservative, as this transient exposure has been compared with NOAELs from long-term studies. Exposure to airborne bendiocarb would be expected to be transient because air levels would be expected to decline due to settlement of particles, natural ventilation of treated premises and the progressive reduction of bendiocarb in the carpet by repeated vacuuming.

It is considered that, based on the assessment of the risks to human health, bendiocarb can be included on Annex I of the BPD.

The indoor scenario used for the environmental risk assessment has assumed treatment on hard surfaces against crawling insects (such as ants and cockroaches) using a crack and crevice treatment in rooms prone to frequent wet cleaning (such as kitchens and bathrooms). The use of Ficam W in rooms where frequent wet cleaning is likely must be restricted to crack, crevice and spot applications, and areas inaccessible to day-to-day cleaning (such as behind kitchen cupboards and appliances). Whilst the risk quotient slightly exceeds 1 when indoor plus outdoor use for domestic and commercial scenarios are combined (under the assumption that outdoor treatments are directly released into surface waters), tonnage data supplied by the Applicant is considered to remove the unacceptable risk. It is the overall conclusion of the UK CA that if used in the manner prescribed above then Ficam W (containing bendiocarb) will not pose an unacceptable risk to surface waters through losses to STP via drains. However, any future increase in application or use pattern should be re evaluated for risk by MS at product authorisation.

Indoor use of Ficam W against fleas can be expected, which would involve application to soft furnishings and carpets, where losses to the aquatic compartment following wet cleaning of carpets and treated furniture are possible, most likely via shampooing. However, it has been assumed that exposure via this route will, in reality, be very low, since treatments should be left in place with no cleaning (shampooing or vacuuming) for a certain period for full control to be achieved. As this is a professional product, and since it contains a substance with residual activity (i.e. ideal for controlling pests that reproduce in situ), it will only be used where it can be left undisturbed for a reasonable period to achieve maximum effectiveness. Label instructions recommending a minimum period for applied product to be left in place (depending on product efficacy) will reduce the likelihood of freshly applied bendiocarb being removed to landfill following vacuuming or washings down the drain following shampooing.

The risk assessment presented to address the use of Ficam W outdoors can be considered as restricted in terms of both frequency (a single annual treatment was assumed for resistance reasons) and scale (small scale via domestic properties was used with 0.2 % use assumed). From the results presented, the use of Ficam W outdoors does not pose an unacceptable risk to surface waters via STP. As noted above, whilst the risk quotient slightly exceeds 1 when indoor plus outdoor use for domestic and commercial scenarios are combined (under the assumption that outdoor treatments are directly released into surface waters), tonnage data supplied by the Applicant is considered to remove the unacceptable risk. Given this, use around the perimeter of buildings to treat for ants, along with wasp and wild bees’ nests should continue to be allowed. However, bearing in mind the principles of good practice, where relevant, clear label instructions should be given to avoid, as far as is practicable, exposure



situations where release to surface water via STP cannot be excluded (such as application to drains and/or their immediate vicinity). The risks from direct application to soil have not been assessed, so such use should also be excluded through labelling. The data on the active substance and the insecticide products have demonstrated sufficient efficacy against a large range of insects (e.g. cockroaches and ants) for inclusion into Annex I to be recommended. Bendiocarb is a carbamate insecticide and some resistance to carbamates has been found to varying degrees, depending on the pest species and location. Data have been provided that shows that although there is a potential for resistance to occur the applicant has proposed an adequate resistance management strategy. In addition, it is proposed that information is added to the label of bendiocarb-containing products to prevent/reduce the potential for resistance to occur (see section 3.3). It is considered that the submitted data and information on resistance are sufficient to support Annex I inclusion of the active substance. The physico-chemical properties of the active substance and biocidal products have been evaluated and are deemed acceptable for the appropriate use, storage and transportation of the active substance and biocidal products.

3.2. Decision regarding Inclusion in Annex I

The active substance bendiocarb shall be included in Annex I to Directive 98/8/EC as an active substance for use in product–type 18 (insecticides, acaricides and products to control other arthropods), subject to the following specific provisions:

• The active substance bendiocarb, as manufactured, shall have a minimum purity of 97 %.

• In view of the risks identified for human health, products containing bendiocarb must be

used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to operators can be reduced to an acceptable level by other means.

• In view of the absence of a dietary risk assessment, products containing bendiocarb shall

not be authorised for contact with food and/or feedstuff unless it can be demonstrated in the application for product authorisation that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

• In view of the absence of a risk assessment for use by amateurs, products containing

bendiocarb shall not be authorised for this use unless it can be demonstrated in the application for product authorisation that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.



• In view of the potential risks to foraging bees following treatment of a nuisance bee nest, where relevant, action should be taken to prevent foraging bees gaining access to the treated nest, preferably by removing the combs or blocking the nest entrances.

• In view of the potential risk to the aquatic environment due to wet cleaning of treated

surfaces, products containing bendiocarb should not be authorised for use on surfaces that are prone to frequent wet cleaning, other than crack and crevice or spot treatments, unless it can be demonstrated in the application for product authorisation that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

• In view of the absence of a risk assessment for the aquatic environment following direct

application to soil, products containing bendiocarb shall not be authorised for this use unless it can be demonstrated in the application for product authorisation that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate risk mitigation measures.

3.3. Elements to be taken into account by Member States when authorising products

No dietary risk assessment has been carried out. Therefore, food and/or feedstuff must not come into contact with the product. In order to avoid food and/or feedstuff coming into contact with the product, where relevant a warning statement that the product should not be used directly on food and/or feedstuff nor on surfaces upon which food and/or feedstuff are prepared, stored or consumed, and that food, feedstuff, food and feedstuff preparing equipment, eating utensils and water storage tanks should be covered should be added to the labelling. Examples of safety phrases relating to food and feedstuffs are as follows:

• Do not apply directly to surfaces on which food or feed is stored, prepared or eaten.

• Cover food, food preparing equipment and eating utensils before application.

• Cover water storage tanks before application. Should applications be made for products containing bendiocarb that may lead to residues in food or feed, Member States shall verify the need to set new or amended existing maximum residue levels (MRLs) according to Regulation (EC) No 470/2009 or Regulation (EC) No 396/2005, and take any appropriate risk mitigation measures ensuring that the applicable MRLs are not exceeded. With regard to exposure of occupants of treated premises, where relevant labelling should indicate that products containing bendiocarb should not be applied to clothing and bedding that will come into direct contact with occupants, and that fabric that has been treated should be allowed to dry and air before being handled.



When evaluating products containing bendiocarb Member States should take into account cumulative exposure from biocidal uses of bendiocarb (in accordance with Article 10(1) of directive 98/8/EC) using agreed EU guidance where possible. With regard to environmental exposure, where relevant labelling should indicate that outdoor use of products containing bendiocarb should be restricted to areas where release to surface water can be avoided as far as is reasonably practicable. For example, products should not be applied directly to drains or their immediate vicinity. With regard to both environmental exposure and resistance, labelling should indicate that application of products containing bendiocarb should be limited to a maximum of six indoors and one outdoors per year per premises (this leads to simultaneity factors of 0.82 and 0.2 % respectively), unless it can be demonstrated in the application for product authorisation that more frequent use of the product is acceptable. In view of the fact that bendiocarb is a carbamate insecticide and some resistance to carbamates has been found to varying degrees, there is a potential for resistance to bendiocarb to occur. Product labelling should therefore provide information to prevent/reduce the potential for resistance to occur as part of a resistance management strategy. Labelling should indicate that where an extended period of control is required, treatments should be alternated with products with different modes of action. Labelling should require that levels of effectiveness should be monitored, and instances of reduced effectiveness should be investigated for possible evidence of resistance, noting that sanitary conditions and the proximity of untreated refuse can contribute to the risk of re-infestation. Finally, labelling should warn that in cases where label rates are correctly applied, but fail to give the expected level of control, and resistance is demonstrated, use of any product containing the same class of chemistry should cease. With regard to efficacy, where relevant labelling should direct the user to recommend to the householder that the treatment remains undisturbed for a minimum period (dependent upon the pest being treated against to ensure that newly hatched offspring are exposed).

3.4. Requirement for further information

It is considered that the evaluation has shown that sufficient data have been provided to verify the outcome and conclusions, and permit the proposal for the inclusion of bendiocarb in Annex I to Directive 98/8/EC.

3.5. Updating this Assessment Report

This Assessment Report may need to be updated periodically in order to take account of scientific developments and results from the examination of any of the information referred to in Articles 7, 10.4 and 14 of Directive 98/8/EC. Such adaptations will be examined and finalised in connection with any amendment of the conditions for the inclusion of bendiocarb in Annex I to the Directive.



Appendix I: List of endpoints

Chapter 1: Identity, Physical and Chemical Properties, Classification and

Labelling

Active substance (ISO Common Name) Bendiocarb

Product-type 18 (Insecticides, acaricides and products to control other arthropods)

Identity

Chemical name (IUPAC) 2,2-dimethyl-1,3-benzodioxol-4-yl methylcarbamate

Chemical name (CAS) 1,3-Benzodioxol-4-ol, 2,2-dimethyl-, 4-(N-methylcarbamate)

CAS No 22781-23-3

EC No 245-216-8

Other substance No. CIPAC No. 232

Minimum purity of the active substance as manufactured (g/kg or g/l)

g/kg

970

g/l

-

% w/w

97

% v/v

-

Identity of relevant impurities and additives (substances of concern) in the active substance as manufactured (g/kg)

The identity and concentrations of the impurities in Bendiocarb, and the additives are confidential.

Molecular formula C11H13NO4

Molecular mass 223.23

Structural formula

N

O

O

OO



Physical and chemical properties

Melting point (state purity) 129 °C (purity: 98.5 %)

Boiling point (state purity) Not measurable, substance decomposes

Temperature of decomposition 264 °C

Appearance (state purity) At 23 - 26 oC and 101.3 kPa:

Physical state: Crystalline powder (purity: 98.5 %) Colour: Beige (purity: 98.5 %) Odour: None (purity: 98.5 %)

Relative density (state purity) 1.29 at 20 °C (purity: 99.0 %)

Surface tension 63.29 mN/m at 20 ºC (purity: 98.9 %)

Vapour pressure (in Pa, state temperature) 1.9 x 10-3 Pa at 20 °C (purity: 99.8 %) 4.6 x 10-3 Pa at 25 °C (purity: 99.8 %)

Henry’s law constant (Pa m3 mol -1) 1.54 x 10-3 Pa m3 mol-1 (calculated)

Solubility in water (g/l or mg/l, state temperature) Results at 20 °C (purity: 99.3 %)

pH 3 – 5: 0.31 g/l

pH 7: 0.28 g/l

pH 9 - 11: 0.03 g/l (significant hydrolysis)

Solubility in organic solvents (in g/l or mg/l, state temperature)

Results at 20 °C (purity: 99.3 %):

Acetone: 150 – 200 g/l Dichloromethane: 200 – 300 g/l Ethyl acetate: 60 – 75 g/l n-Hexane: 0.225 g/l Methanol: 75 – 100 g/l p-Xylene: 11.7 g/l

Stability in organic solvents used in biocidal products including relevant breakdown products

Not applicable, the product will not be formulated with organic solvents.

Partition coefficient (log POW) (state temperature)

log Pow = 1.7 at 25 °C

The partition coefficient was determined to be independent of temperature and pH.

Hydrolytic stability (DT50) (state pH and temperature)

pH_5__: 1116 h (25 ºC)

major metabolite: pyrogallol (30 % of a.s)

pH_7__: 48.1 h (25 ºC)

major metabolite: NC 7312 (87.9 % of a.s)

pH_9__: 0.73 h (25 ºC)


Dissociation constant Not accessible as Bendiocarb hydrolyses rapidly in alkaline solution

UV/VIS absorption (max.) (if absorption > 290 nm state ε at wavelength)

Spectra confirm the chemical structure



Photostability (DT50) (aqueous, sunlight, state pH)

DT50 = 187 d (extrapolated for natural sunlight), major metabolite NC 7312 (max. ~ 12 %), with up to 40 % reported as a mixture of unidentified polar products that could not be isolated or identified separately.

Quantum yield of direct phototransformation in water at Σ > 290 nm

Not available

Flammability Bendiocarb is not highly flammable according to EC Test Method A.10. It shows no spontaneous combustion behaviour at temperatures up to 200 oC. Tests for flammability on contact with water and pyrophoric properties were not conducted, as experience in use show negative results would be obtained.

Explosive properties No positive results were obtained with respect to thermal and mechanical sensitivity.

Classification and proposed labelling

with regard to physical/chemical data Not Classified

with regard to toxicological data T: R23: Toxic by inhalation T: R25: Toxic if swallowed Xn: R21: Harmful in contact with the skin

with regard to fate and behaviour data N: R53: May cause long-term adverse effects in the aquatic environment.

with regard to ecotoxicological data N: R50: Very toxic to aquatic organisms.



Chapter 2: Methods of Analysis

Analytical methods for the active substance

Technical active substance (principle of method) High Performance Liquid Chromatography using UV detection for the analysis of Bendiocarb and impurities in the active substance and formulated product. The method was suitably validated.

Impurities in technical active substance (principle of method)

Analytical methods for residues

Soil (principle of method and LOQ) High Performance Liquid Chromatography using Mass Spectrometry, for the analysis of Bendiocarb in soil. The method was suitably validated. Limit of quantification (LOQ): 5 µg kg-1

Air (principle of method and LOQ) Liquid Chromatography, using Mass Spectrometry, for the analysis of Bendiocarb in air. The method was suitably validated. Limit of quantification (LOQ) = 0.12 µg/m3

Water (principle of method and LOQ) High Performance Liquid Chromatography using UV detection for the analysis of Bendiocarb residues in drinking water. The method was suitably validated. Limit of quantification (LOQ): 0.1 µg/l

High Performance Liquid Chromatography using Mass Spectrometry, for the analysis of Bendiocarb in drinking and surface water. The method was suitably validated. Limit of quantification (LOQ): 0.05 µg/l

Body fluids and tissues (principle of method and LOQ)

Capillary Gas Chromatography, using Mass Selective Detection, for the analysis of Bendiocarb in whole blood. The method was suitably validated.

Limit of quantification (LOQ): 50 ng/ml

Food/feed of plant origin (principle of method and LOQ for methods for monitoring purposes)

Relevant when an active substance is used to treat food-handling surfaces or to treat surfaces when uncovered food is present. This is not the case for bendiocarb, therefore, an analytical method is not required. Food/feed of animal origin (principle of method and

LOQ for methods for monitoring purposes)



Chapter 3: Impact on Human Health

Absorption, distribution, metabolism and excretion in mammals

Rate and extent of oral absorption: In rats, following single (up to 10 mg kg-1) and repeated (0.125 mg/kg bw/d) administration, bendiocarb was rapidly and extensively absorbed.

At these dose levels, an oral absorption value of 100 % is considered appropriate.

Rate and extent of dermal absorption: There are no data available on absorption following dermal exposure to bendiocarb. Data are available on two representative bendiocarb formulations. The dermal absorption of an aqueous dilution (Ficam W) and a dustable powder (Ficam D) were tested in vitro on human skin. However, it is noted that the powder was not moistened when applied to the skin and so, it is not considered appropriate to use the dermal absorption value from the study for the purposes of risk characterisation.

A dermal absorption value of 5 % for bendiocarb was derived from study on the aqueous dilution.

Rate and extent of inhalation absorption: There are no data on the absorption of bendiocarb following inhalation exposure. However, based on the almost complete absorption from the gastro-intestinal tract, it can be predicted that it will be well absorbed from the respiratory tract. Therefore, a worst-case default of 100 % absorption following inhalation exposure is proposed.

Distribution: Once absorbed, bendiocarb and/or its metabolites are widely distributed around the body.

Potential for accumulation: Bendiocarb does not appear to have potential for bioaccumulation.

Rate and extent of excretion: In the rat, elimination of bendiocarb and/or its metabolites after oral administration is rapid, occurs mainly in the urine and is complete by 48 hours after dosing.

Toxicologically significant metabolite(s) None.

Acute toxicity

Rat LD50 oral Rat: 25-156 mg kg bw-1 in males and 27-40 mg kg bw-1 in females.

Rat LD50 dermal Rat: 566 - 800 mg kg bw-1.

Rat LC50 inhalation Rat: 0.61 mg l-1 in males and 0.47 mg l-1 in females.

Skin irritation Not classified.

Eye irritation Not classified



Skin sensitization (test method used and result) Negative in a Buehler test.

Repeated dose toxicity

Species/ target / critical effect Inhibition of erythrocyte and brain cholinesterase activity is considered to be the most sensitive marker of toxicity in rats and dogs.

Lowest relevant oral NOAEL / LOAEL NOAELacute/medium-term: 1.0 mg/kg bw/d (112-day dog study).

NOAELlong-term: 0.65 mg/kg bw/d (2-year dog study).

Lowest relevant dermal NOAEL / LOAEL NOAEL: 1.67 mg/kg bw/d (21-day rabbit study).

Lowest relevant inhalation NOAEL / LOAEL NOAEC: 2 mg m-3 equivalent to a systemic dose equivalent of 0.6 mg/kg bw/d (13-week rat study).

Genotoxicity Bendiocarb gave a positive result in an in vitro cytogenicity assay on human lymphocytes with metabolic activation. However, it was negative in several other in vitro (bacterial reverse mutation assays and unscheduled DNA synthesis assay) tests and in three in vivo assays (clastogenicity, chromosome aberrations in bone marrow and dominant lethal mutations in germ cells). The available data do not support classification for mutagenicity.

Carcinogenicity

Species/type of tumour No treatment-related tumours identified in lifetime studies in rats or mice exposed to bendiocarb in the diet.

lowest dose with tumours Not applicable.

Reproductive toxicity

Species/ Reproduction target / critical effect No treatment-related effects on fertility.

Lowest relevant reproductive NOAEL / LOAEL >18 mg/kg bw/d.

Species/Developmental target / critical effect Post-implantation losses occurred only in the presence of maternal toxicity in both rats and rabbits. A slight delay in ossification in rabbit foetuses, secondary to maternal toxicity, was attributed to bendiocarb but was not sufficient to classify for developmental toxicity.

Developmental toxicity

Lowest relevant developmental NOAEL / LOAEL Rat: NOAEL of 2 mg/kg bw/d for maternal and foetal effects.

Rabbit: NOAEL of 1 mg/kg bw/d for maternal effects and 2.5 mg/kg bw/d for foetal effects.



Neurotoxicity / Delayed neurotoxicity

Species/ target/critical effect No signs of delayed neurotoxicity were reported in hens following a single oral gavage dose of bendiocarb that resulted in mortalities.

Lowest relevant developmental NOAEL / LOAEL. NOAELneurotoxicity : >757 mg kg bw-1

Summary Value Study Safety factor

ADI (if residues in food or feed) Not Required N/A N/A

Oral/Dermal AEL (acute) 0.01 mg/kg bw/d 112-d dog study 100

Oral/Dermal AEL (medium-term) 0.01 mg/kg bw/d 112-d dog study 100

Oral/Dermal AEL (long-term) 0.0065 mg/kg bw/d

2-year dietary study in the dog

100

Inhalation AEL (acute) 0.006

13-week rat inhalation study

100

Inhalation AEL (medium-term) 0.006


100

Inhalation AEL (long-term) 0.003


200

Drinking water limit Not Required N/A N/A

ARfD (acute reference dose) Not Required N/A N/A

Acceptable exposure scenarios (including method of calculation)

Professional users Exposure route: Combined dermal and inhalation

Method of calculation: MOE and AEL

Scenario Values used in the assessment

MOE Exposure/AEL

Mixing/loading Ficam W from the HDPE container + application by spray 133 0.8

Production of active substance: N/A (Technical bendiocarb is manufactured outside the EU).

Formulation of biocidal product Formulated infrequently in the EU over 5 days per annum. Production line is a closed system. Loading and packaging carried out in semi-ventilated areas by people wearing appropriate PPE. Neither inhalation or dermal exposure is expected.

Intended uses Ficam W is diluted with water and applied by spray to treat a wide spectrum of public health and stored-product insect pests.



Secondary exposure

Exposure route: Dermal, inhalation and oral routes Method of calculation: MOE, AEL and reverse-reference

1. Acute/medium-term dermal exposure

NOAEL of 1.0 mg/kg bw/d (112-day oral dog study)

Scenario Infant Child Adult MOE Exposure/AEL MOE Exposure/AEL MOE Exposure/AEL Adult, child and infant come into contact with smooth, treated surfaces 25000 0.004 27778 0.0036 35714 0.0028 Infant exposed to soft furnishings before vacuuming. 120 0.83 N/A N/A N/A N/A Infant exposed to soft furnishings after vacuuming. 1429 0.07 N/A N/A N/A N/A Infant, child or adult sleeps on treated mattress 222 0.45 417 0.24 417 0.24 Adult launders contaminated clothing N/A N/A N/A N/A 263 0.38

2. Long-term dermal exposure

NOAEL of 0.65 mg/kg bw/d (2-year dietary study in dogs)

Scenario Infant Child Adult MOE Exposure/AEL MOE Exposure/AEL MOE Exposure/AEL Adult, child and infant come into contact with smooth, treated surfaces 16250 0.006 18056 0.006 23214 0.004 Infant exposed to soft furnishings before vacuuming. 155 0.65 N/A N/A N/A N/A Infant exposed to soft furnishings after vacuuming. 929 0.11 N/A N/A N/A N/A Infant, child or adult sleeps on treated mattress 144 0.69 271 0.37 271 0.37 Adult launders contaminated clothing N/A N/A N/A N/A 171 0.59



3. Acute/medium-term oral exposure

NOAEL of 1.0 mg/kg bw/d (112-day oral dog study)

Scenario Infant MOE Exposure/AEL Contamination of hands and ingestion of deposits before vacuuming 1667 0.06 Contamination of hands and ingestion of deposits after vacuuming 16667 0.006

NOAEL of 0.5 mg kg-1 (single oral administration in cats)

Scenario Reverse reference scenario

Ingestion of residue from treated carpet before vacuuming to achieve the NOAEL a kitten would need to ingest pure bendiocarb from 961.5 cm2 of treated carpet before vacuuming. Ingestion of residue from treated carpet after vacuuming to achieve the NOAEL a kitten would need to ingest pure bendiocarb from 11363.6 cm2 of treated carpet following vacuuming.

4. Long-term oral exposure

NOAEL of 0.65 mg/kg bw/d (2-year dietary study in dogs)

Scenario Infant

MOE Exposure/AEL

Contamination of hands and ingestion of deposits before vacuuming 1083 0.09 Contamination of hands and ingestion of deposits after vacuuming 10833 0.009

5. Acute/medium-term inhalation exposure

13-week rat inhalation study, a NOAEC of 2 mg m-3 (equivalent to 0.6 mg/kg bw/d)

Scenario Infant Child Adult

MOE Exposure/AEL MOE Exposure/AEL MOE Exposure/AEL

Inhalation of dislodged residues during vacuuming

97 1.03 107 0.93 171 0.58

6. Long-term inhalation exposure

13-week rat inhalation study, a NOAEC of 2 mg m-3 (equivalent to 0.6 mg/kg bw/d)





Inhalation of dislodged residues during vacuuming

4615 0.02 6000 0.02 8571 0.01

Combined exposure

Exposure route: Dermal, inhalation and oral routes Method of calculation: MOE and AEL

Long-term NOAEL: 0.65 mg/kg bw/d (2-year dietary study in dogs)

Acute/medium-term NOAEL: 1.0 mg/kg bw/d (112-day oral dog study) for infrequent combined exposures



Long-term – Adult and child exposed to dislodgeable residues. Adult laundering of clothing. N/A N/A 433 0.23 295 0.34

Acute/medium term- Adult exposed following mixing/loading from HDPE containers, spraying and dislogeable residues N/A N/A N/A N/A 141 0.71

Long-term - Infant exposed dermally, inhalationally and via ingestion to dislodged residues before vacuuming 131 0.76 N/A N/A N/A N/A

Long-term - Infant exposed dermally, inhalationally and via ingestion to dislodged residues after vacuuming 295 0.34 N/A N/A N/A N/A

Non-professional users Not required as product is professional only.

Indirect exposure as a result of use N/A



Chapter 4: Fate and Behaviour in the Environment

Hydrolysis of active substance and relevant metabolites (DT50) (state pH and temperature)

pH_5__: 1116 h (25 ºC)

major metabolite: pyrogallol (30 % of a.s)

pH_7__: 48.1 h (25 ºC)


pH_9__: 0.73 h (25 ºC)


Photolytic / photo-oxidative degradation of active substance and resulting relevant metabolites

DT50 = 187 d (extrapolated for natural sunlight), major metabolite NC 7312 (max. ~ 12 %), with up to 40 % reported as a mixture of unidentified polar products that could not be isolated or identified separately.

Readily biodegradable (yes/no) No

Biodegradation in seawater No data

Distribution in water / sediment systems (active substance)

Arnold 1984: Bendiocarb was rapidly hydrolysed (99 % in 2 days) resulting in the formation of NC 7312 (2,2-dimethyl-l,3-benzodioxol-4-ol) which was further degraded.

Purser (1997a): Immediately after (14C)-bendiocarb application >97 % of applied radioactivity (AR) was recovered in the surface water. Over the incubation period a slow transfer of radioactive material to the sediment was observed with the surface water containing 31 to 35 % of applied radioactivity after 30 days. The radioactivity extracted from the sediment with acetonitrile increased from ca 3 % of applied radioactivity at day 0 to 7 to 13 % after 30 days. The major component in the surface water and sediment acetonitrile extracts in all samples analysed up to 7 days after application was (14C)-bendiocarb. DT50 (system) of 9d (20°C) = 17.1 d (12°C)

Purser (1997b):Under anaerobic conditions, [14C]-bendiocarb (labelled in the phenyl ring) was rapidly degraded under the conditions tested. The DT50 was determined to be ~ 4.7 d at 20 °C, which has been adjusted by the UK CA (using equation 25; TGD) to 12 ºC (mean EU temperature), to 8.9 d. he major metabolite was NC 7312 (2,2-dimethyl-l,3-benzodioxol-4-ol) which reached maximum mean levels of 86.8 % of applied radioactivity in the associated water after 30 d and 16 % in the sediment after 120 d. In addition to NC 7312, polar metabolites, an unextracted residue and volatile products (the majority of which were present as carbon dioxide) were observed.



Distribution in water / sediment systems (metabolites)

Arnold 1984: The rate of degradation of NC 7312 was influenced by microcosm type and was greatly accelerated in the presence of sediment. The half- lives of NC 7312 were: <2 weeks (+ sediment), 6 weeks (unfiltered water) and an estimated 10 weeks (filtered water).

Purser (1997a): At 7 days NC 7312 was present at similar levels to that of bendiocarb in the sediment and water extracts. Thereafter, the proportion of parent compound decreased, such that at the end of the study period the amount detected declined to ca 7 % of applied radioactivity.

Mineralization Arnold 1984: The increased rate of 14CO2 evolution in the sediment/water microcosms (35 % in 8 weeks) compared with that in both non-filtered and filtered water alone (24 % and 7 % respectively) suggests enhanced microbial activity in the presence of sediment.

Purser (1997a): Between 21 and 30 days, however, significant amounts of the applied radioactivity were trapped in the ethanediol traps (2.8 to 4.7 %). The quantity of radioactivity in the ethanolamine traps increased with time, and contained a total of 20 to 22 % of the applied radioactivity after 30 days.

Non-extractable residues Arnold 1984: Non reported

Purser (1997a): Unextracted sediment residues increased from <0.1 % to 15 to 23 % of AR over the incubation period.

Route and rate of degradation in soil

Laboratory studies (range or median, with number of measurements, with regression coefficient)

DT50lab (12 °C aerobic): 9.9 d (worst-case) or 6.5 d (mean, n=2) [excluding sand soil]

DT90lab (20 °C, aerobic): Not reported

Mineralization (aerobic) 20 – 35 % on day 21 (Allen, 1989)

55 % after 26 weeks (Mackenzie and Allen, 1990)

DT50lab (20 °C, anaerobic): Not available.

degradation in the saturated zone: Not available.

Non-extractable residues 55 – 65% of AR on day 21 (Allen, 1989)

~45% of AR after 26 weeks (Mackenzie and Allen, 1990)

Relevant metabolites - name and/or code, % of applied a.i. (range and maximum)

The principal degradation product was NC 7312 (max. 14% on day 0, then further degraded into pyrogallol (max. 2% of AR on day 1) (Allen, 1989)

The primary degradation product was NC 7312 (max. of only 2% of AR) followed by further rapid breakdown and



the formation of pyrogallol together with other unidentified polar metabolites (each accounted for less than 0.5% of AR) (Mackenzie and Allen, 1990).

Field studies (state location, range or median with number of measurements)

DT50f: Not available

DT90f: Not available

Anaerobic degradation Not available

Soil photolysis DT50: 7.8 h (extrapolated for natural sunlight)

Non-extractable residues Soil bound material also significantly increased in the irradiated samples from 15.8 % at 3.5 hours to 40.5 % at 21.1 hours.

Relevant metabolites - name and/or code, % of applied a.i. (range and maximum)

No significant amounts of degradation products could be detected in the acetonitrile extracts from the irradiated or non-irradiated soil samples. HPLC analysis showed that the radioactivity was not due to bendiocarb or its hydrolysis products (NC 7312 and pyrogallol).

Soil accumulation and plateau concentration Not available

Laboratory studies (range or median, with number of measurements, with regression coefficient)

DT50lab (12 °C aerobic): 6.5 (mean)

Adsorption/desorption

Ka , Kd

Kaoc , Kdoc

pH dependence (yes / no) (if yes type of

dependence)

Ka 0.1 – 1.85, Kd 0.24 – 4.44

Kaoc 33.65 (arithmetic mean), Kdoc 94.6 (arithmetic mean) l kg-1

No

Fate and behaviour in air

Direct photolysis in air DT50 = 13.2 h estimated

Quantum yield of direct photolysis Not available

Photo-oxidative degradation in air Latitude: .N/A.. Season: ...N/A. DT50 ..N/A

Volatilization Not applicable.

Monitoring data, if available

Soil (indicate location and type of study)

Not available Surface water (indicate location and type of study)

Ground water (indicate location and type of study)

Air (indicate location and type of study)



Chapter 5: Effects on Non-target Species

Toxicity data for aquatic species (most sensitive species of each group) ACTIVE: Bendiocarb

Species Time-scale Endpoint Toxicity

Fish

Cyprinodon variegatus 96 h LC50 0.86 mg l-1

Salmo gairdneri 78 d NOEClarval growth 0.07 mg l-1

Invertebrates

Daphnia magna 48 h EC50 0.038 mg l-1

Daphnia magna 21 d NOECreproduction 0.00088 mg l-1

Algae

Pseudokirchneriella subcapitata

72 h ErC50

NOErC

0.408 mg l-1

0.087 mg l-1

Microorganisms

Activated sewage sludge 3 h EC50 70.1 mg l-1 (corrected for hydrolysis)

Toxicity data for aquatic species (most sensitive species of each group) Metabolite: NC 7312

Species Time-scale Endpoint Toxicity

Fish

Salmo gairdneri 96 h LC50 10 mg l-1

Invertebrates

Daphnia magna Straus 48 h EC50 25.4 mg l-1

Algae

Desmodesmus subspicatus 72 h ErC50

NOErC

88.3 mg l-1

0.95 mg l-1

Microorganisms

Not available

Effects on earthworms or other soil non-target organisms

Acute toxicity to Eisenia fetida andrei

14 d LC50 188 mg kg-1 soil

Reproductive toxicity to …………………………

Not available



Effects on soil micro-organisms

Nitrogen mineralization Not available

Carbon mineralization NOEC > 50 mg l-1

Effects on terrestrial vertebrates

Acute toxicity to mammals

Not available

Acute toxicity to birds

Dietary toxicity to birds

Reproductive toxicity to birds

Effects on honeybees

Acute oral toxicity Not available

Acute contact toxicity Not available

Effects on other beneficial arthropods

Acute oral toxicity Not available

Acute contact toxicity Not available

Acute toxicity to ………………………………….. Not available

Bioconcentration

Bioconcentration factor (BCF) 5.55 l kg-1 (calculated)

6.0 l kg-1 (experimentally determined)

Depuration time (DT50)

(DT90)

> 89 % in 1d

> 97 % in 3d

Level of metabolites (%) in organisms accounting for > 10 % of residues

No identification was possible due to negligible



Chapter 6: Other End-Points

No other end-points are considered relevant.



Appendix II: List of Intended Uses

Bendiocarb has been evaluated for its use in insecticide formulations for controlling a wide range of crawling and flying insects such as cockroaches, houseflies, mosquitoes, ants, beetles, fleas, wasps, moths, crickets and silverfish (product type 18).

The Applicant has submitted 1 biocidal product for evaluation in support of Annex I inclusion:

• Ficam W – a concentrate product containing 80 % pure bendiocarb. The product is diluted with water to control a wide spectrum of public health and stored-product insect pests. The product is intended for use both indoors and outdoors by professional operators only at an application rate of 96 mg bendiocarb m-2.

Use

For use as an insecticide, in and around buildings for the control of a wide range of insect pests in Public Health and Industry.

Field(s) of application:

In and around buildings including houses, blocks of flats, hotels, restaurants, hospitals, food factories, warehouses. Use in continuously occupied areas as a band/spot or crack and crevice treatment only.

Pest/ target:

For the control of cockroaches, ants, fleas, flies, stored product pests, bed bugs, carpet pests, wasps, wild bees, silverfish and other bristle tails, ground beetles, earwigs, crickets, booklice, spiders and woodlice.

Spraying equipment: Apply with any suitable hand held or knapsack sprayer.

Directions for use: Mixing and Spraying:

Apply as a coarse spray, to just short of run off. For treatment of exposed surfaces use a flat-fan nozzle with an output of 0.5 - 0.7 litre per minute. Such nozzles are normally marked 8002 or 02F80. To spray cracks and crevices, use a pin-stream nozzle or special crack and crevice extension.

The spray should be applied evenly to all surfaces with a 0.5 band width, e.g. at wall/floor junctions carpets etc and crack & crevices where insects might find cover. To spray large areas of surface e.g. carpets, proceed as above but spray overlapping bands 0.5 metres apart to ensure an even coverage of spray.

Spray can be applied to any surface that is not damaged by water alone. The product will remain active for many weeks; the residual life of the deposit will vary depending upon the cleanliness and nature of the surface to which it is applied. Therefore re-treat as necessary. Treated premises can be re-occupied by children, pets and other animals once the sprayed surfaces are dry. After the spray is dry it is recommended that rooms are ventilated. As



this is a residual insecticide it is not recommended to wash off or vacuum the area until the infestation is under control.

Pest control:

Ants: A barrier spray around buildings, paying particular attention to doors, windows and other entry points, will prevent entry of foraging ants from outside. Spray in and around nests, runs and foraging areas.

Bed Bugs: Spray bed frames and mattresses and cracks and crevices in adjacent wall and floor areas. Do not spray bed linen or other materials which come into direct contact with occupants of the bed.

Carpet pests: Spray infested carpets paying particular attention to edges of fitted carpets.

Cockroaches: Spray hiding, runway and scavenging areas paying particular attention to cracks and crevices and areas behind or under machinery, kitchen equipment or pipework, which are usual cockroach harbourages. For complete eradication of infestations, it is essential to conduct spray treatment in conjunction with treatment of inaccessible areas such as service ducts and roof voids with a suitable insecticidal dust.

Fleas: Spray floor coverings and furniture particularly in areas likely to be infested including sleeping areas of dogs and cats but not directly on people, animals or bedding.

Flies: Add 10g of sugar/L water and stir to dissolve. Identify where flies settle and spray the surface. The sugar acts as a bait encouraging flies to remain on the treated surface long enough to pick up a lethal dose of insecticide.

Stored Product Pests: Spray the entire structure of storage areas after cleaning but exclude areas, which come into contact with food.

Wasps and Wild Bees: Spray nest and its entrances thoroughly. Action should be taken to prevent foraging bees gaining access to treated bees nests preferably by removing the combs or blocking nest entrances. After treatment nest should be removed, if possible, and disposed of in a controlled manner i.e. Pesticide Waste Disposal Scheme.

Silverfish and Firebrats: Spray cracks and crevices in cupboards and bookshelves and around kitchen fittings.

Other Crawling Pests including Ground Beetles, Earwigs, Crickets, Booklice, Spiders, Woodlice. Spray wherever these pests are found in buildings.



Data on the active substance bendiocarb and the biocidal product have demonstrated sufficient efficacy against insects for inclusion onto Annex I to be recommended. Data so far from published studies has demonstrated the occurrence of resistance to bendiocarb in insects (cockroaches, houseflies and mosquitoes), and the variability in the extent of such resistance. As resistance to bendiocarb is a well-known and long-established problem, measures to manage resistance are well-established. These measures should be taken into account when authorising products containing bendiocarb.



Author(s) Year Title

Source (where different from company)

Company, Report No.

GLP (where relevant) / (Un)Published

Data Protection Claimed

(Yes / No)

Owner

Brehm, M. 1992b Estimation of the Photo-Oxidative Degradation of Bendiocarb (Schering Code No. ZK 52 020) in the Atmosphere

Schering AG Agrochemicals Division

Report No: A90133

7 June 1992

GLP n/a. Unpublished.

Y Bayer Crop-Science AG

Brennecke, R. 1998 Independent Laboratory Validation of Method EM F-05/98-0“Rapid Multimethod for Verification and Determination of Toxic Pesticides in Whole Blood by Means of Capillary GC-MS”

Bayer AG, Crop Protection, Germany

Report No: C002476

21 December 1998

Not GLP. Unpublished


Bright, A.A.S. 1988a Determination of the Relative Density of Bendiocarb

Schering Agrochemicals Ltd.

Report No: A90081

4 May 1988

GLP. Unpublished.


Bright, A.A.S. 1988b 63-10 Dissociation Constant – Bendiocarb (R000174)


Report No: A90087

6 May 1988

GLP. Unpublished.


Bright, A.A.S. 1988c Bendiocarb: Determination of the Partition Coefficient Between n-Octanol and Water at 25°C


Report No: A90075

6 May 1988

GLP. Unpublished.






Company, Report No.



(Yes / No)

Owner

Erstling, K. 2005a Storage stability of bendiocarb WP80 - (Packaging material: HDPE) - Interim report after 1 year

Bayer Industry Services GmbH & Co, OHG, Germany

Report No: M-237354-02-1

13 September 2005

GLP. Unpublished.

Y Bayer Crop-Science GmbH

Erstling, K. 2005b Storage stability of bendiocarb WP80 - (Packaging material: HDPE) - Interim report after 1 year


Report No: M-237354-02-1

13 September 2005

GLP. Unpublished.


Erstling, K. 2006a Storage Stability of Bendiocarb WP 80 (packaging material: HDPE) –Final Report


Report No: M-237354-03-01

26 September 2006

GLP. Unpublished.


Erstling, K. 2006b Storage Stability of Bendiocarb WP 80 (packaging material: HDPE) – Final Report


Report No: M-237354-03-01

26 September 2006

GLP. Unpublished.


European Chemicals Bureau (ECB)

2002 TNsG 2002. European Commission, DG Environment -Technical Notes for Guidance: Human Exposure to Biocidal Products – Guidance on Exposure Estimation (June 2002).

N Public domain

European Chemicals Bureau (ECB)

2003 European Chemicals Bureau (2003): Part 1 - Technical Document On Risk assessment in support of Directive 93/67/EEC (risk assessment for new notified substances); EC Regulation No. 1488/94 (Risk assessment for Existing Substances); and Directive 98/8/EC (concerning the placing of biocidal products on the market)

N Public domain





Company, Report No.



(Yes / No)

Owner

Evans, R.G. 1991e The Laboratory Activity of Ficam W, Ficam Plus and Ficam Dust Against the Booklouse Liposcelis bostrychophilus

Schering Agrochemicals Ltd, UK

Report No: A90884, M-167600-01-1

25 January 1991

Not GLP. Unpublished.


Evans, R.G. 1991a The Laboratory Activity of Ficam W, Ficam Plus and Ficam Dust Against the Ground-Beetle Pterostichus melanarius


Report No: A90878, M-167594-01-1

25 January 1991

Non-GLP. Unpublished


Evans, R.G. 1991b The Laboratory Activity of Ficam W, Ficam Plus and Ficam Dust Against the Earwig Forficula auricularia


Report No: A90883, M-167599-01-1

25 January 1991

Non-GLP. Unpublished.


Evans, R.G. 1991c The Laboratory Activity of Ficam W, Ficam Plus and Ficam Dust Against the House Cricket Acheta domesticus


Report No: A90885, M-167601-01-1

25 January 1991



Evans, R.G. 1991d The Laboratory Activity of Ficam W, Ficam Plus and Ficam Dust Against the Woodlice Species Porcellio scaber and Armadillidium vulgare


Report No: A90881, M-167597-01-1

25 January 1991







Company, Report No.



(Yes / No)

Owner

Lee, C.Y., Yap, H.-H. and Chong, N.-L

1996 Insecticide toxicity on the adult German cockroach, Blattella germanica (L.) (Dictyoptera: Blattellidae)

School of Biological Sciences, Malaysia

Malaysian Journal of Science (17A), 1 – 9.

Report No: M-263749-01-1

1996

Not GLP. Published.

N Public domain

Lemon, R.W. 1970a Bendiocarb – The Activity of NC 6897 Against the Common Garden Ant (Acanthomyops niger (syn. Lasius niger)

Schering Agrochemicals Limited, UK

Report No: A90675, M-167393-01-1

15 May 1970



Lemon, R.W. 1970b Bendiocarb – The Activity of NC 6897 and Baygon Against the Clothes Moth and Two Species of Carpet Beetle


Report No: A90690, M-167498-01-1

22 April 1970



Lemon, R.W. 1971a Ficam W (containing NC 6897) – NC 6897 Topical Application Test Against the American Cockroach (Periplaneta Americana)

Fisons Agrochemical Division, UK

Report No: A90652, M-167370-01-1

9 February 1971



Lemon, R.W. 1971b Bendiocarb – The Activity of NC 6897 Against Pharaoh’s Ant Monomorium pharaonis and the House Cricket Acheta domesticus


Report No: A90676, M-167394-01-1

3 November 1971



Bendiocarb (assessment report as finalised on 22.09.11).

Documents

Transcript of Bendiocarb (assessment report as finalised on 22.09.11).